Trial · NCT04163458
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 54
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Fertilized (2 Pronuclei [2PN]) Oocytes | On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) | Fertilized oocytes with 2PN were regarded as correctly fertilized. |
| Secondary | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | 10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation) | A blood serum βhCG test was obtained 10-14 days after blastocyst transfer. If the test was positive according to the local laboratory's reference ranges, this confirmed a positive βhCG. |
| Secondary | Clinical Pregnancy Rate | 5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation) | Clinical pregnancy was based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound. |
| Secondary | Ongoing Pregnancy Rate | 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation) | Ongoing pregnancy was based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound |
| Secondary | Early Pregnancy Loss | 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation) | Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy. |
| Secondary | Follicular Development on Stimulation Day 6 | At stimulation Day 6 | The total number of follicles and the number of follicles per size category were reported. |
| Secondary | Follicular Development on Last Day of Stimulation | At last day of stimulation (up to 20 stimulation days) | The total number of follicles and the number of follicles per size category were reported. |
| Secondary | Serum Follicle-stimulating Hormone (FSH) Concentration | At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation) | The concentration of serum FSH was measured. The median and IQR of FSH levels on stimulation day 6, End of stimulation and Oocyte Retrieval visit are presented. |
| Secondary | Serum Anti-Müllerian Hormone (AMH) Concentration | At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening) | The concentration of serum AMH was measured. The median and IQR of AMH levels on End of stimulation and End of Trial are presented. |
| Secondary | Human Chorionic Gonadotropin (hCG) Concentration | At Day 6 and last day of stimulation (up to 20 stimulation days) | The concentration of hCG was measured. The median and IQR of hCG levels on stimulation day 6 and End of stimulation are presented. |
| Secondary | Luteinizing Hormone (LH) Concentration | At Day 6 and last day of stimulation (up to 20 stimulation days) | The concentration of LH was measured. The median and IQR of LH levels on stimulation day 6 and End of stimulation are presented. |
| Secondary | Progesterone (P4) Concentration | At Day 6 and last day of stimulation (up to 20 stimulation days) | The concentration of P4 was measured. The median and IQR of P4 levels on stimulation day 6 and End of stimulation are presented. |
| Secondary | Estradiol (E2) Concentration | At stimulation Day 6 and last day of stimulation (up to 20 stimulation days) | The concentration of E2 was measured. The median and IQR of E2 levels on stimulation day 6 and End of stimulation are presented. |
| Secondary | 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 | Number of Metaphase II (MII) Oocytes | On day of oocyte retrieval (up to 22 days after start of stimulation) | Maturity stage was assessed prior to undergoing ICSI. Maturity stage was categorized as germinal vesicle, metaphase I, metaphase II, degenerated or other. |
| Secondary | Fertilization Rate | On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) | Fertilization rate(%) is the number of 2PN oocytes divided by the number of oocytes retrieved. |
| Secondary | Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval | 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 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) |
| Secondary | Total Gonadotropin Dose | Up to 20 stimulation days | The gonadotropin starting dose was 225 IU for the first 5 days, followed by individual adjustments according to the participant's follicular response. Dose adjustment should be 75 IU per adjustment. Gonadotropin was to be initiated within 3 days of confirmed downregulation. |
| Secondary | Number of Stimulation Days | Up to 20 stimulation days | Calculated by start dates and end dates. |
| Secondary | Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS) | ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS) | OHSS was defined as the total of early OHSS with onset ≤9 days after triggering of final follicular maturation, and late OHSS with onset \>9 days after triggering of final follicular maturation. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04163458/registered