N/A
N=396
Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)
In Vitro Fertilization
Bottom Line
View on ClinicalTrials.gov: NCT00702546 ↗Enrolled (actual)
396
Serious AEs
1.0%
Results posted
May 2015
Primary outcome: Primary: Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) — 32.1; 41.4 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- corifollitropin alfa (Drug); recFSH (follitropin alfa) (Biological); gonadatropin releasing hormone (GnRH) antagonist ganirelix (Drug); human chorion gonadatropin (hCG) (Drug); progesterone (Biological); placebo-recFSH (follitropin alfa) (Drug); placebo-corifollitropin alfa (Drug); open-label recFSH (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) |
32.1; 41.4 | — |
| SECONDARY Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy |
13.6; 10.0 | — |
| SECONDARY Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants in Follow up Study With an Ecotopic Pregnancy |
1.3; 0.0 | — |
| SECONDARY Percentage of Participants in Follow up Study With a Clinical Pregnancy |
28.6; 40.0 | — |
| SECONDARY Percentage of Participants in Follow up Study With a Vital Pregnancy |
24.7; 36.0 | — |
| SECONDARY Percentage of Participants With an Ongoing Pregnancy |
23.4; 36.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants from whom embryos have been cryopreserved in base study P05690, of which at least one embryo is thawed for use in a subsequent FTET cycle;
- Able and willing to give written informed consent.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00702546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.