Trial · NCT01121666
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved (Per Protocol Population) | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes |
| Primary | Number of Oocytes Retrieved (Intention-to-treat Population) | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes |
| Secondary | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | Day 8 of stimulation | The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point. |
| Secondary | E2 Concentration at Day 8 and at Day of hCG Administration | Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment) | The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration. |
| Secondary | Total Dose of r-hFSH Administered | Day of hCG administration (after maximum 16 days of r-hFSH treatment) | Total dose of r-hFSH required was assessed. |
| Secondary | Quality of Oocytes Retrieved | 34-36 hours after hCG administration | Number of patients with ovum pick-up |
| Secondary | Fertilisation Rate of Oocytes | 1 day after ovum pick-up | Fertilisation rate was assessed |
| Secondary | Embryo Quality: Mean Number of Blastomeres | Day 2 of OPU/fertilisation | Main embryo quality parameter "mean number of blastomeres" |
| Secondary | Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts | Day 1, 2, 3 and 5 of OPU/fertilisation | |
| Secondary | Number of Days of r-hFSH Stimulation | At the day of hCG administration, up to 16 days | Mean duration of stimulation was assessed. |
| Secondary | Number of Patients With Cycle Cancellation | Until child birth/miscarriage, up to the end of the study | Number of patients with cycle cancellation was assessed. |
| Secondary | Number of Patients With Good Response | Until child birth/miscarriage, up to the end of the study | Good response was defined as "patients with an oocyte retrieval of four or more oocytes" |
| Secondary | Implantation Rate | Five to six weeks after oocyte retrieval | Defined as fetal sac per embryo transferred. |
| Secondary | Clinical Pregnancy Rate | Five to six weeks after oocyte retrieval | Presence of at least one intrauterine gestational sac. |
| Secondary | Ongoing Pregnancy | Ten weeks after embryo transfer | Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer. |
| Secondary | Live Birth Rate | After childbirth with questionnaire | Patients with liveborn children |
| Secondary | Embryo Quality: Absence of Multinucleation | Day 3 | Main embryo quality parameter "absence of multinucleation" observed. |
| Secondary | Quality of Oocytes Retrieved | At day 4 and 5 | Number of patients with transferred blastocysts |
| Secondary | Quality of Oocytes Retrieved | Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval | Number of embryos per blastocysts transferred |
| Secondary | Clinical Pregnancy Rate (Second Treatment Cycle) | Five to six weeks after oocyte retrieval | Presence of at least one intrauterine gestational sac. |
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.
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GET https://conductscience.org/api/trials/v1/NCT01121666/registered