Trials / Completed
CompletedNCT00702546
Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)
Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 102 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- Female
- Age
- 18 Years – 36 Years
- Healthy volunteers
- Not accepted
Summary
Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.
Detailed description
This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | corifollitropin alfa | Single injection of 100 μg corifollitropin alfa administered under protocol P05690 |
| BIOLOGICAL | recFSH (follitropin alfa) | Daily recFSH administered under protocol P05690 |
| DRUG | gonadatropin releasing hormone (GnRH) antagonist ganirelix | GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690 |
| DRUG | human chorion gonadatropin (hCG) | hCG 5,000 IU or 10,000 IU administered SC under protocol P05690 |
| BIOLOGICAL | progesterone | Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM. |
| DRUG | placebo-recFSH (follitropin alfa) | Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690 |
| DRUG | placebo-corifollitropin alfa | Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690 |
| BIOLOGICAL | open-label recFSH | Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590 |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-06-20
- Last updated
- 2022-02-03
- Results posted
- 2015-05-05
Source: ClinicalTrials.gov record NCT00702546. Inclusion in this directory is not an endorsement.