Trial · NCT01976728
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ovulation Rate | From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks | Calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 6 ng/mL or subjects with confirmed positive serum β-human chorionic gonadotropin (β-hCG) (i.e., 2 positive results) or subjects with a gestational sac documented by transvaginal ultrasound (TVUS). |
| Secondary | Progesterone (P4) Levels | Treatment Days 19, 21, 23, 25, and 27 | Proportion of participants with at least 1 post-baseline P4 level ≥ 10 ng/mL. |
| Secondary | Clinical Pregnancy Rate | 2 to 4 weeks after a second positive serum β-hCG test | Proportion of subjects with presence of gestational sac and fetal heart movement on TVUS after a second positive serum β-hCG test. |
| Secondary | Biochemical Pregnancy Rate | Approximately 14 days after LH surge | Proportion of subjects with a confirmed positive serum β-hCG test after luteinizing hormone (LH) surge. |
| Secondary | LH Surge Detection | Daily from Day 11 until first positive LH surge or until Day 39 | Proportion of subjects with a positive detection of LH surge, based on a Clearblue test which began when follicles with a mean diameter ≥14 mm were documented on TVUS. |
| Secondary | Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm | From treatment Day 10 to treatment Day 21 | Number of follicles with a mean diameter ≥14 mm collected from Days 10 or 11, until LH surge or Day 21. |
| Secondary | Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm | From treatment Day 10 to treatment Day 21 | Number of dominant follicles with a mean diameter ≥18 mm collected from Days 10 or 11, until LH surge or Day 21. |
| Secondary | Luteal Phase Support: Maximum P4 Levels | Treatment Days 19, 21, 23, 25, and 27 | Maximum of post-dose P4 levels collected on treatment Days 19 to 27 are presented. |
| Secondary | Luteal Phase Support: Mean P4 Levels | Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27 | Mean of post-dose P4 levels collected on treatment Days 19 to 27 are presented. |
| Secondary | Change From Baseline in Follicle-stimulating Hormone (FSH) | Baseline (pre-dose), Treatment Day 1, Treatment Day 10 | FSH change from baseline in relation to the first dose (pulse) on Day 1 and Day 10 |
| Secondary | Change From Baseline in LH | Baseline (pre-dose), Treatment Day 1, Treatment Day 10 | LH change from baseline in relation to first dose (pulse) on Day 1 and Day 10 |
| Secondary | Mean Serum FSH and LH Levels | Treatment Days 1 and Day 10 | Mean FSH and LH levels on Day 1 and Day 10. |
| Secondary | Estradiol (E2) Serum Levels | At treatment Day 1 and Day 10 | E2 serum levels on Day 1 and Day 10. |
| Secondary | Type, Intensity, and Frequency of Adverse Events (AEs) | From treatment Day 1 to end-of-trial, approximately 10 weeks | An AE was defined as any untoward medical occurrence in a subject taking part in a clinical trial. Proportion of subjects with any AE (serious or non-serious) and intensity of AEs (classified as mild, moderate or severe) are presented. |
| Secondary | Hematology, Clinical Chemistry, and Urinalysis | From treatment Day 1 to end-of-trial, approximately 10 weeks | Proportion of subjects with markedly abnormal changes in hematology, clinical chemistry, and urinalysis. |
| Secondary | Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS) | From treatment Day 1 to end-of-trial, approximately 10 weeks | Proportion of subjects reporting OHSS classified as mild, moderate, or severe. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01976728/registered