Trial · NCT03228680
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved | 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval) | The number of oocytes retrieved was recorded at the oocyte retrieval visit. |
| Secondary | Clinical Pregnancy Rate | 5-6 weeks after transfer (up to approximately 3 months after start of stimulation) | Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer. |
| Secondary | Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate | 13-15 days after transfer (up to approximately 1.5 months after start of stimulation) | Defined as positive serum beta-hCG test 13-15 days after transfer. |
| Secondary | Vital Pregnancy Rate | 5-6 weeks after transfer (up to approximately 3 months after start of stimulation) | Vital pregnancy was 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 (up to approximately 3 months after start of stimulation) | Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by the number of blastocysts transferred. |
| Secondary | Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response | End-of-stimulation (up to 20 stimulation days) | |
| Secondary | Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk | End-of-stimulation (up to 20 stimulation days) | |
| Secondary | Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | On the day of oocyte retrieval (up to 22 days after start of stimulation) | Defined as proportion of participants grouped according to the number of oocytes retrieved. The proportion of participants with \<4 oocytes (low response), 4-7 oocytes (moderate response), 8-14 oocytes (targeted response), 15-19 oocytes (hyperresponse) and ≥20 oocytes (severe hyperresponse) are presented. |
| Secondary | Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population | On the day of oocyte retrieval (up to 22 days after start of stimulation) | |
| Secondary | Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS) | ≤9 days after triggering of final follicular maturation | |
| Secondary | Proportions of Participants 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 | Defined as proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented. |
| Secondary | Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade) | >9 days after triggering of final follicular maturation | Defined as proportions of participants with late OHSS (including OHSS of moderate/severe grade). Late OHSS was defined as OHSS with onset \>9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe. |
| Secondary | Number of Follicles on Stimulation Day 6 | At Day 6 of stimulation | Defined as the number of follicles observed in both ovaries at the last transvaginal ultrasound (TVUS) in the stimulation phase (on stimulation Day 6). |
| Secondary | Number of Follicles at End-of-stimulation | End-of-stimulation (up to 20 stimulation days) | Defined as the number of follicles observed in both ovaries at the last TVUS in the stimulation phase (end-of-stimulation). |
| Secondary | Size of Follicles on Stimulation Day 6 | At Day 6 of stimulation | Defined as size characteristics of follicles on stimulation Day 6. Average size of 3 largest follicles has been presented in this endpoint. |
| Secondary | Size of Follicles at End-of-Stimulation | End-of-stimulation (up to 20 stimulation days) | Defined as size characteristics of follicles at end-of-stimulation. Average size of 3 largest follicles has been presented in this endpoint. |
| Secondary | Fertilization Rate | Day 1 after oocyte retrieval (up to approximately 22 days after start of stimulation) | 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 | Day 3 after oocyte retrieval (up to approximately 24 days after start of stimulation) | 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 fragmentation ≤20% on Day 3. |
| Secondary | Number and Quality of Blastocysts | Day 5 after oocyte retrieval (up to approximately 26 days after start of stimulation) | Number of embryos (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. |
| Secondary | Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6 | At Day 6 of stimulation | The median and inter-quartile range (IQR) of FSH and LH levels on stimulation Day 6 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.
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