Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART) (NCT00505752), a randomized phase 2 study. The primary outcome is Number of Fertilized Oocytes (2 Pronuclei [PN]).

2. Clinical Question

The registry record describes a dose-finding study of a long-acting follicle stimulating hormone in participants undergoing assisted reproductive technology. Its brief summary says the investigational treatment was compared with follitropin alfa in relation to the number of fertilized oocytes. The posted comparisons use the 50 mcg AS900672-Enriched arm as the reference for the 100 mcg and 150 mcg arms, and also compare the follitropin alfa arm with that reference.

The primary measure is the number of oocytes with two pronuclei, a laboratory indicator of fertilization. Clinical pregnancy is listed as a secondary outcome. Those endpoints address different stages: the primary measure concerns fertilization, while the secondary outcome records clinical pregnancy at a later stated assessment time. The registry record does not report a single combined endpoint covering both.

3. Trial Design

This was a Phase 2, randomized, parallel-group, active-comparator, dose-finding study. The registry record describes it as multicenter and assessor-blinded. The masking entry is single; details beyond the assessor-blinded description are not reported in the registry record. The study was completed, with enrollment listed as 520 participants.

Participants were assigned to one of four treatment groups: AS900672-Enriched at 50 mcg, 100 mcg, or 150 mcg, or follitropin alfa at 150 IU. Recombinant human chorionic gonadotropin is also listed among the interventions, but further details of its role are not reported in the registry record. Arm descriptions beyond the intervention names are not reported.

The primary outcome was the number of fertilized oocytes with two pronuclei, assessed on ovum pick-up day. The registry specifies that this was 34–38 hours after r-hCG administration, at the end of a stimulation cycle described as approximately 21 days. The primary outcome population was defined as all randomized participants, with the analyzed number indicating participants evaluable for the measure.

The registry record does not report the allocation ratio, the sequence-generation procedure, the details of concealment, or the study’s original sample-size justification. It also does not report a statistical analysis plan or a complete account of the masking procedures. Those details should not be inferred from the randomized and assessor-blinded design labels.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intention-to-treat (ITT) population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Number of Fertilized Oocytes (2 Pronuclei [PN]), measured over Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}]).

The primary endpoint is the number of oocytes fertilized by intracytoplasmic sperm injection that showed two pronuclei, abbreviated 2PN. The registry describes intracytoplasmic sperm injection as a procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two pronuclei is described as the first sign of successful fertilization observed during in vitro fertilization and is usually seen after intracytoplasmic sperm injection. The resulting zygote is termed 2PN.

This is a count outcome summarized as a mean and standard deviation for each treatment group. It captures the number of oocytes reaching a specified early laboratory stage, rather than a later pregnancy outcome. That makes it relevant to a study evaluating stimulation and fertilization in assisted reproductive technology, while also distinguishing it from the secondary clinical pregnancy measure.

The stated assessment time is ovum pick-up day, 34–38 hours after r-hCG administration and at the end of the stimulation cycle, described as approximately 21 days. The registry describes the primary population as intention-to-treat, including all randomized participants, while clarifying that the reported analyzed number refers to participants evaluable for the measure. Details of how unevaluable outcomes were handled are not reported in the registry record.

7. Results Posted in the Registry

• AS900672-Enriched 100 Microgram (Mcg): mean 8.70 versus 7.00 on control; difference 1.70 (95% CI 0.51 to 2.89), standardized effect d = 0.35; z-test p = 0.005.
• AS900672-Enriched 150 Microgram (Mcg): mean 9.20 versus 7.00 on control; difference 2.20 (95% CI 0.87 to 3.53), standardized effect d = 0.41; z-test p = 0.001.
• Follitropin Alfa 150 IU: mean 6.70 versus 7.00 on control; difference -0.30 (95% CI -1.38 to 0.78), standardized effect d = -0.07; z-test p = 0.587.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Percentage of Participants With Clinical Pregnancy

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • AS900672-Enriched 100 Microgram (Mcg): 40.8% (49/120) versus 39.1% (50/128) on control; risk difference 1.8 percentage points (95% CI -10.4 to 14.0), risk ratio 1.05 (0.77–1.42); unadjusted two-proportion z-test p = 0.776.
  • AS900672-Enriched 150 Microgram (Mcg): 35.2% (43/122) versus 39.1% (50/128) on control; risk difference -3.8 percentage points (95% CI -15.8 to 8.2), risk ratio 0.90 (0.65–1.25); unadjusted two-proportion z-test p = 0.533.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between AS900672-Enriched 100 Microgram (Mcg) and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between AS900672-Enriched 150 Microgram (Mcg) and the control. The interval gives the range of effects that remain compatible with the data.

Clinical pregnancy is the posted secondary outcome. Its group percentages range from 35.2% to 43.8% across the four arms, with analyzed numbers from 120 to 128. The registry gives a follow-up time of day 35–42 after r-hCG administration, at the end of a stimulation cycle described as approximately 21 days.

The broad pattern does not mirror a simple upward progression across the three investigational doses: the percentage is not highest in the 150 mcg group. The active-comparator arm has the highest posted percentage. These descriptive patterns differ from the primary endpoint’s higher mean 2PN counts in the two higher AS900672-Enriched dose groups relative to the 50 mcg group. The outcomes measure different stages, so the registry results do not establish that a primary-endpoint difference translates into a corresponding pregnancy difference.

The posted unadjusted secondary comparisons are limited to the 100 mcg and 150 mcg groups against the 50 mcg group. Their confidence intervals for the risk differences include zero, and their unadjusted p-values are 0.776 and 0.533. The registry record does not report a comparison of the follitropin alfa group with the 50 mcg group for this secondary outcome, nor does it report sponsor analyses for the secondary endpoint.

Unadjusted secondary findings carry less weight when several outcomes or comparisons are considered, because the chance of at least one apparently unusual result can increase across multiple tests. The registry record does not report whether a multiplicity procedure was prespecified or applied. The secondary endpoint should therefore be treated as supportive descriptive evidence, not as a definitive confirmation or contradiction of the primary result.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Percentage of Participants With Clinical Pregnancy

9. Statistical Interpretation

10. Statistical Methods Explained

What does the mean represent?

The primary endpoint is a count of 2PN oocytes for each participant. A group mean describes the average count among participants evaluated in that treatment group. It does not mean that every participant had that number of fertilized oocytes. The registry also reports a standard deviation, which describes how widely participant-level values are spread around the mean. A larger standard deviation indicates greater variability in the observed counts within that group.

In general, a mean is useful for summarizing a numerical outcome, but it does not show the full shape of the outcome distribution. Counts can be skewed or include many low values, and group averages alone do not reveal those features. The registry record does not report additional distribution summaries or participant-level data for this endpoint.

How should the mean differences be read?

The posted mean differences compare each listed group with the AS900672-Enriched 50 mcg group. A positive difference means that the listed group’s observed mean was higher than the reference group’s mean; a negative difference means it was lower. For example, the posted difference for the 100 mcg group is 1.7, and that for the 150 mcg group is 2.2. The follitropin alfa comparison is -0.3.

These are unadjusted comparisons calculated from posted summary statistics. They are not evidence of an adjusted analysis, and the registry record reports no analyses in its analysis listing. The record does not explain whether the sponsor conducted additional analyses outside the posted registry results.

What does a p-value tell the reader?

In general, a p-value measures how compatible observed data are with a specified null model, under the assumptions of the statistical test. A smaller p-value indicates less compatibility with that model; it is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of a difference. Here, the unadjusted p-values are 0.005 for the 100 mcg comparison, 0.001 for the 150 mcg comparison, and 0.587 for the follitropin alfa comparison.

The registry record does not state the statistical test used by the sponsor, the prespecified significance threshold, or a procedure for adjusting for multiple comparisons. The p-values accompanying the posted recalculations therefore describe unadjusted comparisons and should be interpreted with that limitation in mind.

Why can variation matter?

In general, over-dispersion occurs when the variation in count outcomes is greater than expected under a simple count model. It can affect standard errors and the reliability of statistical inferences if the analysis assumes less variation than is present. The reported standard deviations show meaningful spread in this outcome, but the registry record does not report a dispersion assessment or a model-based analysis. It is not possible to determine from the group summaries alone whether over-dispersion was formally evaluated.

More generally, count outcomes may have distributional features that are not captured by a mean and standard deviation alone. The record does not report whether the sponsor used a count-specific model, a transformation, or another method. Those analysis details are not reported in the registry record and should not be inferred from the posted summary statistics.

How does randomization fit into the interpretation?

Random assignment is intended, in general, to make comparison groups similar on average at the start of a trial. It supports interpretation of between-group differences, but does not remove uncertainty, correct missing outcome data automatically, or guarantee that every measured and unmeasured characteristic is balanced in a particular trial. The registry identifies the study as randomized but does not report details of sequence generation, allocation concealment, or baseline balance in the registry record for this outcome.

The record identifies the primary population as intention-to-treat, defined as all participants randomized to study treatment, while stating that the analyzed number is the number evaluable for the measure. This distinction matters: the population definition does not establish that every randomized participant contributed an observed endpoint. The handling of participants without an evaluable outcome is not reported in the registry record.

What role do the confidence intervals play?

In general, a confidence interval gives a range of estimates compatible with the observed data and the method used to calculate the interval. Its width reflects precision: narrower intervals indicate greater precision under the method’s assumptions, while wider intervals indicate more uncertainty. For the primary comparisons, the intervals for the two higher investigational doses exclude zero; the interval for the follitropin alfa comparison includes zero. The registry record does not report the interval method or whether the sponsor’s own inferential analysis used the same approach.

Taken together, means, standard deviations, mean differences, p-values, and confidence intervals provide different information. Means describe observed group averages; standard deviations describe spread among individuals; differences describe contrasts; p-values summarize compatibility with a null model; and intervals convey uncertainty about the contrasts. None alone provides a complete account of the trial’s design, analysis choices, or clinical relevance.

11. Confidence Intervals and Precision

The primary mean differences are accompanied by confidence intervals. The interval for the 100 mcg comparison excludes zero, as does the interval for the 150 mcg comparison. The interval for follitropin alfa includes zero. In general, an interval that includes zero is compatible with no mean difference under the interval’s calculation method; an interval excluding zero is less compatible with that value under the same method. Neither pattern establishes the probability that a particular effect is true.

Precision is also reflected in interval width. In general, an estimate with a wider interval allows a broader range of values and is less precise than one with a narrower interval, assuming comparable methods and measures. The primary group standard deviations range from 4.2 to 6.0, while analyzed group sizes range from 122 to 131. Those summaries help describe variability and the amount of observed information, but they do not replace the intervals for the contrasts.

The registry record does not report the confidence-interval method or a sponsor analysis that would allow comparison with the unadjusted recalculations. The posted intervals should therefore be read as uncertainty ranges associated with the reported comparisons, not as a guarantee that the true difference falls within them. They also do not account for any unreported multiplicity adjustment or analysis decisions.

Precision is distinct from clinical importance. The registry record does not state a minimum difference in 2PN oocytes that would be considered clinically important. Statistical uncertainty can be described from the posted results, but the clinical meaning of differences of this size cannot be decided from the endpoint summaries alone.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial’s original design justification. For these continuous outcomes, the values are participants per arm, not total events. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The trial’s own original sample-size assumptions are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed for an 80% chance of detecting the specified effect under those assumptions, if that effect were the true one. The 90% power column applies the same interpretation at a higher target chance of detection. These are design-planning quantities, not descriptions of what the completed trial achieved.

The planning scenarios use 100%, 75%, and 50% of the observed effect. The smaller the effect a future study aims to detect, the more participants per arm the calculation requires. This is because smaller differences are harder to distinguish from random variation, all else being equal. Planning values also depend on the assumptions used, so they should not be treated as universal requirements for another study.

These figures are not observed power. They are illustrative sample-size calculations based on the observed effects and the stated assumptions, rather than a measure of the probability that the completed trial detected an effect.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 1.700; pooled standard deviation σ = 4.798.
2. n = 2 × (1.96 + 0.842)² × 4.798² / 1.700² = 125.0, rounded up to 126 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 1.7                      # observed difference in means
sigma <- 4.79784118119806                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(505752)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 126 (80% power), 168 (90% power)
 75% of observed effect: n per arm = 223 (80% power), 298 (90% power)
 50% of observed effect: n per arm = 501 (80% power), 670 (90% power)
power.t.test: 126 
Simulated power at n = 126 per arm: 0.804 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The study compares multiple treatment groups and reports a primary endpoint as well as a secondary clinical pregnancy outcome. Multiple comparisons can make isolated unadjusted p-values less persuasive because testing more hypotheses creates more opportunities for a nominally unusual result. In general, multiplicity procedures are used to control error across a planned family of tests. The registry record does not report whether such a procedure was specified or used.

The primary comparisons posted for the 100 mcg and 150 mcg groups and the follitropin alfa group are unadjusted. The secondary comparisons are also unadjusted, and the registry lists no reported analyses for that outcome. The analysis plan, testing hierarchy, and any correction for multiple testing are not reported in the registry record. It is therefore not possible to say whether the posted comparisons were the full set of analyses conducted or how they relate to any prespecified confirmatory claims.

The primary outcome description defines the intention-to-treat population as all randomized participants and states that the analyzed number signifies participants evaluable for the measure. The analyzed numbers are not identical across treatment groups or across the primary and secondary outcomes. The reasons for those differences, the number of missing endpoint values, and the method used to handle missing data are not reported in the registry record.

In general, missing outcome data can affect comparisons if the likelihood or reasons for missingness differ between groups or relate to the outcome. The registry record does not provide enough detail to assess that possibility. It also does not report whether analyses included all randomized participants, used imputation, or applied another missing-data method beyond the stated evaluable-participant counts.

These omissions limit assessment of the inferential framework. They do not establish that a particular method was or was not used; they mean that it is not reported in the registry record. The distinction between a registry summary and a complete statistical analysis plan is important when interpreting unadjusted comparisons and outcome populations.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: ectopic pregnancy (1.6%), cholecystitis (0.8%), abortion spontaneous (0.8%), heterotopic pregnancy (0.8%), ruptured ectopic pregnancy (0.8%).

The registry lists participants affected by serious adverse events and the number at risk in each treatment group. The serious-event figures are 5 of 132 for AS900672-Enriched 50 mcg, 5 of 128 for 100 mcg, 4 of 128 for 150 mcg, and 6 of 132 for follitropin alfa 150 IU. These are group-level counts in the registry record; they do not by themselves establish that an event was caused by the assigned treatment.

The listed serious event terms and percentages include ectopic pregnancy at 1.6%, and cholecystitis, spontaneous abortion, heterotopic pregnancy, ruptured ectopic pregnancy, and ovarian hyperstimulation syndrome at 0.8% each. These listings describe the reported serious-event terms, not a comparison adjusted for differences between groups. The registry does not provide detailed event narratives in the registry record.

Deaths are not reported in the registry record. Other adverse events affected 90, 85, 84, and 82 participants in the four treatment groups, respectively. Interpretation of these counts depends on the registry’s event definitions and observation procedures, which are not further described in the record.

16. What the Result Does, and Does Not, Mean

The posted primary outcome shows different observed mean numbers of 2PN oocytes across the four treatment groups. The two higher AS900672-Enriched dose groups had higher means than the 50 mcg group, and their unadjusted mean-difference intervals exclude zero. The follitropin alfa mean was close to the 50 mcg mean, and its unadjusted interval includes zero. These statements describe the endpoint and comparisons in the registry record; they do not establish a treatment recommendation.

The endpoint is an early fertilization measure, not a pregnancy or live-birth outcome. The registry lists clinical pregnancy as a secondary outcome, and its group pattern is not a simple continuation of the primary endpoint pattern. The record does not report a combined analysis connecting the number of 2PN oocytes to clinical pregnancy, nor does it report further pregnancy outcomes beyond the listed secondary measure.

Statistical significance and clinical importance are different questions. The registry record does not define a clinically important difference in the number of fertilized oocytes. It also does not report a multiplicity procedure, a complete sponsor analysis, or the original sample-size justification. Those omissions constrain how strongly the unadjusted comparisons can support broader conclusions.

Randomization and assessor blinding are relevant features of the reported design, but they do not eliminate uncertainty or resolve missing-data and analysis-plan questions. The posted means and intervals should be read together with the group variability, the evaluable-participant counts, and the limits of the registry reporting. The findings apply to the outcomes and comparisons recorded for this trial; they do not, on their own, establish effects on outcomes that were not reported.

17. Why This Trial Matters Statistically

This trial illustrates why the endpoint chosen for a clinical study matters. The primary outcome is a laboratory count of fertilized oocytes reaching the 2PN stage, whereas the listed secondary outcome is clinical pregnancy. These measures are related to different points in the assisted reproductive technology process and should not be treated as interchangeable. A difference in a laboratory measure does not automatically imply a difference in a later clinical outcome.

The dose-finding design also makes comparison structure important. The posted primary comparisons use the 50 mcg arm as the reference for each other group. That makes the higher-dose mean differences interpretable relative to the lower investigational dose, but it does not by itself establish a formal dose-response trend. The registry record does not report a trend analysis or an adjustment for the multiple treatment comparisons.

The study’s group standard deviations are substantial relative to the means, reinforcing that averages do not describe every participant’s outcome. Confidence intervals add information about uncertainty around comparisons, while p-values alone do not convey effect size or precision. Reading these summaries together is more informative than treating one statistic as a complete result.

Finally, the distinction between registry results and a full statistical analysis plan is consequential. The record identifies the randomized population but reports evaluable counts, and does not describe missing-data handling, multiplicity, or the original sample-size justification. Those gaps are relevant when judging how far the posted estimates support conclusions beyond the observed endpoint summaries.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several trial-specific details needed for a fuller assessment are not reported in the registry record. These include the original sample-size justification, allocation ratio, randomization sequence and concealment procedures, and fuller details of assessor blinding. Although the study is described as multicenter, center-specific results and any adjustment for center are not reported.

The primary outcome is reported as a mean and standard deviation, but the record does not provide participant-level data, distribution summaries, or the sponsor’s analysis method. The posted comparisons are unadjusted recalculations from group summaries, and no sponsor analyses are listed. The statistical test, any model assumptions, and any prespecified analysis choices are not reported in the registry record.

Outcome counts indicate that the analyzed numbers differ across groups and endpoints. Reasons for missing or unevaluable measurements, missing-data handling, and any sensitivity analyses are not reported. The record also does not report whether multiple comparisons were addressed, including comparisons across doses and outcomes.

The registry includes clinical pregnancy as a secondary measure but does not report a comparison with the follitropin alfa arm for that endpoint. It does not report further pregnancy outcomes in the registry record for this trial. The adverse-event summaries provide group counts and selected serious-event terms, but event narratives, attribution details, and deaths are not reported in the registry record. These limits do not establish that additional analyses or information were unavailable elsewhere; they define what can be assessed from the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART) — NCT00505752.
• Registry record last updated 2014-02-13; status last verified 2014-01.
• Results first posted 2013-07-24.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT00505752 is a completed Phase 2, randomized, parallel-group, assessor-blinded, active-comparator, dose-finding study in infertile women undergoing assisted reproductive technology. Enrollment was 520. The study compared AS900672-Enriched at 50 mcg, 100 mcg, and 150 mcg with follitropin alfa at 150 IU.

The primary endpoint was the mean number of 2PN oocytes on ovum pick-up day. Posted means were 7.0, 8.7, 9.2, and 6.7 across the four groups, respectively. Unadjusted comparisons against the 50 mcg group showed positive mean differences for the two higher investigational doses, while the follitropin alfa comparison was close to zero. Clinical pregnancy was the listed secondary outcome.

The registry record does not report the original sample-size justification, complete statistical analysis plan, multiplicity handling, or missing-data methods. The posted unadjusted results therefore require interpretation alongside those reporting limitations.