Trial · NCT03740737
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 69
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of COS | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Defined as at least one intrauterine viable fetus 8-9 weeks after transfer. Data in this endpoint are presented for the fresh cycle and the cryopreserved cycles. |
| Secondary | Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Defined as at least one intrauterine viable fetus 8-9 weeks after transfer. Data in this endpoint are presented for the fresh cycle and the cryopreserved cycles. |
| Secondary | Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Time from start of COS to ongoing pregnancy, including both the fresh and cryopreserved cycles. In the placebo group, no participants achieved an ongoing pregnancy either after 12 calendar months or after 12 study months. |
| Secondary | Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Measured in Number of Cycles Before Achieving Ongoing Pregnancy | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Time from start of COS to ongoing pregnancy, including both the fresh and cryopreserved cycles, measured in number of cycles before achieving ongoing pregnancy. In the placebo group, no participants achieved an ongoing pregnancy either after 12 calendar months or after 12 study months. |
| Secondary | Ongoing Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Defined as the number of intrauterine viable fetuses 8-9 weeks after transfer divided by number of blastocysts transferred. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. One participant can contribute with a range from zero to multiple blastocysts. Data is not shown for placebo arm because no blastocyst transfer was performed in the fresh cycle or cryopreserved cycles. '%' in the unit of measure refers to 'percentage'. |
| Secondary | Clinical Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | Defined at least one gestational sac 5-6 weeks after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. |
| Secondary | Vital Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | Defined at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. |
| Secondary | Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | Defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. One participant can contribute with a range from zero to multiple blastocysts. Data is not shown for placebo arm because no subjects underwent blastocyst transfer in the fresh cycle or cryopreserved cycles. '%' in the unit of measure refers to 'percentage'. |
| Secondary | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 10-14 days after transfer (up to approximately 14 months after start of stimulation) | Defined as positive serum βhCG test 10-14 days after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. |
| Secondary | Proportion of Subjects in the Fresh Cycle With Triggering of Final Follicular Maturation (hCG, With GnRH Agonist, and in Total), Cycle Cancellation and Transfer Cancellation | Up to 5 days after oocyte retrieval (up to 27 days after start of stimulation) | Data in this endpoint are presented for the fresh cycle. |
| Secondary | Number of Follicles on Stimulation Day 5 | On stimulation day 5 | The total number of follicles and the number of follicles per size category are presented |
| Secondary | Number of Follicles at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | The total number of follicles and the number of follicles per size category is reported. |
| Secondary | Size of Follicles on Stimulation Day 5 | On stimulation day 5 | Counted by ultrasound for the right and left ovary for each participant. |
| Secondary | Size of Follicles at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Counted by ultrasound for the right and left ovary for each participant. |
| Secondary | Number of Oocytes Retrieved | On day of oocyte retrieval (up to 22 days after start of stimulation) | The number of oocytes retrieved was recorded at the oocyte retrieval visit. |
| Secondary | Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | On day of oocyte retrieval (up to 22 days after start of stimulation) | Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the \<4 oocytes group. |
| Secondary | Number of Metaphase II Oocytes | On day of oocyte retrieval (up to 22 days after start of stimulation) | The number of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using ICSI are presented. |
| Secondary | Number of Fertilized Oocytes | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | An oocyte was defined as fertilized if it had 2 pronuclei (2PN) at 19h (±2h). |
| Secondary | Fertilization Rate | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | The fertilization rate was defined as the number of 2PN oocytes divided by the number of oocytes retrieved. Fertilization rate relative to oocytes retrieved has been reported. Data is not shown for placebo arm because the mean number of fertilized oocytes was 0 in all subjects, since no subjects had oocytes retrieved or fertilized. |
| Secondary | Number and Quality of Blastocysts on Day 5 After Oocyte Retrieval | On day 5 after oocyte retrieval | Number of blastocysts (total and good-quality) on Day 5 are presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner \& Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher. |
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.
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