Trial · NCT03296527
Registered outcomes61
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 61
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ongoing Pregnancy Rate | 10-11 weeks after transfer | Defined as at least one intrauterine viable fetus 10-11 weeks after transfer. |
| Secondary | Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate | 13-15 days after transfer | Defined as positive βhCG test 13-15 days after transfer. |
| Secondary | Clinical Pregnancy Rate | 5-6 weeks after transfer | Defined as at least one gestational sac 5-6 weeks after transfer. |
| Secondary | Vital Pregnancy Rate | 5-6 weeks after transfer | Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer. |
| Secondary | Implantation Rate | 5-6 weeks after transfer | Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred. |
| Secondary | Ongoing Implantation Rate | 10-11 weeks after transfer | Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred. |
| Secondary | Proportion of Subjects With Extreme Ovarian Responses | Oocyte retrieval visit | Extreme ovarian response defined as \<4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as \<4 oocytes retrieved. |
| Secondary | Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS | Up to 9 days after triggering of final follicular maturation | Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. |
| 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 | End-of-stimulation visit (up to 20 days) or transfer visit | For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk. |
| Secondary | Number of Follicles on Stimulation Day 6 | On stimulation Day 6 | Counted by ultrasound for the right and left ovary for each participant. |
| Secondary | Number of Follicles At End-of-stimulation (up to 20 Stimulation Days) | At end-of-stimulation (up to 20 stimulation days) | Counted by ultrasound for the right and left ovary for each participant. |
| Secondary | Size of Follicles on Stimulation Day 6 | On stimulation Day 6 | Counted by ultrasound for the right and left ovary for each participant. |
| Secondary | Size of Follicles At End-of-stimulation (up to 20 Stimulation Days) | 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 the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation) | 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 the day of oocyte retrieval | 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 | Percentage of Metaphase II (MII) Oocytes | Prior to insemination | The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented. |
| Secondary | Fertilization Rate | On Day 1 after oocyte retrieval | The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved. |
| Secondary | Number and Quality of Embryos | On Day 3 after oocyte retrieval | Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation. |
| Secondary | Circulating Concentrations of Luteinizing Hormone (LH) | On stimulation Day 6 | Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented. |
| Secondary | Circulating Concentrations of LH | End-of-stimulation (up to 20 stimulation days) | Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented. |
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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