Trial · NCT03809429
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | At end-of-stimulation (up to 20 days) | For each participant, the reason for cycle cancellation was recorded |
| Secondary | Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) | At end of transfer (up to 4 weeks) | For each participant, the reason for blastocyst transfer cancellation was recorded. |
| Secondary | Number of Follicles | On stimulation day 6 and at end-of-stimulation (up to 20 days) | The total number of follicles and the number of follicles per size category will be reported |
| 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 number of oocytes |
| Secondary | Number of Metaphase II Oocytes | On day of oocyte retrieval (up to 22 days after start of stimulation) | Only applicable for those inseminated using ICSI |
| Secondary | Fertilization Rate | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | Measured by the number of pronuclei. Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized |
| Secondary | Number of Embryos | On day 3 after oocyte retrieval (up to 25 days after start of stimulation) | The number of embryos (total and good-quality) was reported. Embryo quality is determined by combined assessment of cleavage stage (number of blastomeres/compaction status) and embryo morphology parameters |
| Secondary | Number of Blastocysts | On day 5 after oocyte retrieval (up to 27 days after start of stimulation) | The number of blastocysts (total and good-quality) was reported. Blastocyst quality is assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring is based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells) |
| Secondary | Circulating Concentrations of Follicle-stimulating Hormone (FSH) | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | Blood samples for analysis of circulating concentrations of FSH were drawn. |
| Secondary | Circulating Concentrations of Luteinizing Hormone (LH) | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | Blood samples for analysis of circulating concentrations of LH were drawn |
| Secondary | Circulating Concentrations of Estradiol | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | Blood samples for analysis of circulating concentrations of estradiol were drawn |
| Secondary | Circulating Concentrations of Progesterone | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | Blood samples for analysis of circulating concentrations of progesterone were drawn |
| Secondary | Circulating Concentrations of Inhibin B | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | Blood samples for analysis of circulating concentrations of Inhibin B were drawn |
| Secondary | Total Gonadotropin Dose | Up to 20 days | Calculated by start dates, end dates and daily dose of investigational medicinal product |
| Secondary | Number of Stimulation Days | Up to 20 days | Calculated by start dates and end dates |
| Secondary | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | 13-15 days after transfer (up to approximately 1.5 months after start of stimulation) | Defined as positive serum βhCG test |
| Secondary | Implantation Rate | 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) | Defined as the number of gestational sacs after transfer divided by number of blastocysts transferred |
| Secondary | Clinical Pregnancy Rate | 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) | Defined as at least one gestational sac |
| Secondary | Vital Pregnancy Rate | 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) | Defined as at least one intrauterine gestational sac with fetal heart beat |
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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