Trial · NCT03564509
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of good-quality blastocysts on Day 5 after oocyte retrieval | On Day 5 after oocyte retrieval | Quality of blastocysts was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was 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 cell). |
| Secondary | Number of subjects with at least one good-quality blastocyst on Day 5 after oocyte retrieval | On Day 5 after oocyte retrieval | Quality of blastocysts was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was 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 cell). |
| Secondary | Number of subjects with at least two good-quality blastocysts on Day 5 after oocyte retrieval | On Day 5 after oocyte retrieval | Quality of blastocysts was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was 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 cell). |
| Secondary | Number and quality of embryos on Day 3 after oocyte retrieval | On Day 3 after oocyte retrieval | Embryo quality was assessed by cleavage stage and embryo morphology parameters. The total number of embryos and the number of embryos per quality category were reported. |
| Secondary | Number and quality of blastocysts on Day 5 after oocyte retrieval | On Day 5 after oocyte retrieval | Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was 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). The total number of blastocysts and the number of blastocysts per quality category will be reported. |
| Secondary | Changes in serum hormone levels | Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval | Blood samples for analysis of hormone concentrations were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, last day of stimulation, and at oocyte retrieval. |
| Secondary | Number and size of follicles on stimulation Day 6 | On stimulation Day 6 | Number and size of follicles assessed using transvaginal ultrasound. The total number of follicles and the number of follicles per size category were reported. |
| Secondary | Number and size of follicles at end-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Number and size of follicles assessed using transvaginal ultrasound. The total number of follicles and the number of follicles per size category were reported. |
| Secondary | Positive beta human chorionic gonadotropin (βhCG) rate | 13-15 days after blastocyst transfer | Proportion of patients with positive blood βhCG confirmed by a blood test. |
| Secondary | Clinical pregnancy rate | 5-6 weeks after blastocyst transfer | Clinical pregnancy was defined as at least one gestational sac, either intrauterine or ectopic. |
| Secondary | Vital pregnancy rate | 5-6 weeks after blastocyst transfer | Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat, as assessed by transvaginal ultrasound. |
| Secondary | Ongoing pregnancy rate | 10-11 weeks after blastocyst transfer | Ongoing pregnancy was defined as at least one intrauterine viable fetus, assessed using transvaginal or abdominal ultrasound. |
| Secondary | Number of oocytes retrieved | On the day of oocyte retrieval | |
| Secondary | Number of metaphase II oocytes | On the day of oocyte retrieval | |
| Secondary | Number of fertilised 2 pronuclei (2PN) oocytes | On day 1 after insemination | |
| Secondary | Total gonadotropin dose | At end-of-stimulation (up to 20 stimulation days) | The daily dose of FE 999302 or placebo, and follitropin delta were recorded. |
| Secondary | Total number of stimulation days | At end-of-stimulation (up to 20 stimulation days) | The start and end dates of administration of FE 999302 or placebo, and follitropin delta were recorded. |
| Secondary | Incidence of cycle cancellation | At end-of-stimulation (up to 20 stimulation days) | Cycle cancellation due to poor ovarian response or excessive ovarian response. |
| Secondary | Serum concentrations of FE 999302 | On stimulation Day 1 (prior to first dose of FE 999302 or placebo), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days) | |
| Secondary | Incidence of ovarian hyperstimulation syndrome (OHSS) (early or late, any grade) | From stimulation Day 1 to end-of-trial (estimated maximum of 4 months from start of stimulation) | Early OHSS was defined as OHSS with onset less than equal to 9 days after triggering of final follicular maturation. Late OHSS was defined as OHSS with onset greater than 9 days after triggering of final follicular maturation. All OHSS cases were graded 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.
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