Trial · NCT04773353
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ongoing pregnancy rate | 10-11 weeks after embryo transfer | Ongoing pregnancy is defined as at least one intrauterine viable fetus 10-11 weeks after embryo transfer. |
| Secondary | Positive beta human chorionic gonadotropin (βhCG) rate | 13-15 days after embryo transfer | Positive βhCG is defined as positive serum βhCG test 13-15 days after embryo transfer. |
| Secondary | Clinical pregnancy rate | 5-6 weeks after embryo transfer | Clinical pregnancy is defined as at least one gestational sac 5-6 weeks after embryo transfer. |
| Secondary | Vital pregnancy rate | 5-6 weeks after embryo transfer | Vital pregnancy is defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after embryo transfer. |
| Secondary | Implantation rate | 5-6 weeks after embryo transfer | Implantation rate is defined as the number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred. |
| Secondary | Ongoing implantation rate | 10-11 weeks after embryo transfer | Ongoing implantation rate is defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred. |
| Secondary | Proportion of subjects with extreme ovarian responses | On day of oocyte retrieval (up to 22 days after start of stimulation) | Extreme ovarian response is defined as \<4, ≥15 or ≥20 oocytes retrieved. |
| Secondary | Proportion of subjects with early ovarian hyperstimulation syndrome (OHSS) (including OHSS of moderate/severe grade) and/or preventive interventions for early OHSS | ≤9 days after triggering of final follicular maturation | The proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS will be presented. |
| Secondary | Proportion of subjects with cycle cancellation due to poor or excessive ovarian response or embryo transfer cancellation due to excessive ovarian response / OHSS risk | At end-of-stimulation (up to 20 stimulation days) or transfer visit | The proportion of participants with cycle cancellation due to poor or excessive ovarian response or embryo transfer cancellation due to excessive ovarian response / OHSS risk will be presented. |
| Secondary | Number of follicles on stimulation Day 6 | On stimulation Day 6 | Counted by ultrasound for the right and left ovary. |
| Secondary | Number of follicles at end-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Counted by ultrasound for the right and left ovary. |
| Secondary | Size of follicles on stimulation Day 6 | On stimulation Day 6 | Measured by ultrasound for the right and left ovary. |
| Secondary | Size of follicles at end-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Measured by ultrasound for the right and left ovary. |
| Secondary | Number of oocytes retrieved | On day of oocyte retrieval (up to 22 days after start of stimulation) | The number of oocytes retrieved will be 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) | |
| Secondary | Percentage of metaphase II oocytes (only applicable for those inseminated using intracytoplasmic sperm injection [ICSI]) | On day of oocyte retrieval (up to 22 days after stimulation) | The percentage of metaphase II oocytes to oocytes retrieved for participants where all oocytes were inseminated using ICSI will be presented. |
| Secondary | Fertilisation rate | On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) | The fertilisation rate is defined as the number of fertilized oocytes with 2 pronuclei divided by the number of oocytes retrieved. |
| Secondary | Number and quality of embryos on day 3 after oocyte retrieval | On Day 3 after oocyte retrieval (up to 25 days after start of stimulation) | The total number of embryos and the number of good-quality embryos will be counted on Day 3. A good-quality embryo is defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation. |
| Secondary | Circulating concentrations of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) | On stimulation day 6 | Blood samples for analysis of circulating concentrations of FSH and LH will be drawn. |
| Secondary | Circulating concentrations of estradiol | On stimulation day 6 | Blood samples for analysis of circulating concentrations of estradiol will be drawn. |
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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