N/A
N=1,509
Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
In Vitro Fertilization
Bottom Line
View on ClinicalTrials.gov: NCT00702273 ↗Enrolled (actual)
1,509
Serious AEs
0.3%
Results posted
Nov 2014
Primary outcome: Primary: Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) — 47.2; 44.9 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 150 µg Corifollitropin Alfa (Drug); 200 IU RecFSH/Follitropin beta (Days 1 to 7) (Biological); Placebo for Corifollitropin Alfa (Drug); Placebo for RecFSH/Follitropin beta (Drug); 200 IU RecFSH/Follitropin beta (Days 8 to hCG) (Biological); Ganirelix (Drug); hCG (Biological); Progesterone (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) |
47.2; 44.9 | — |
| SECONDARY Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy |
8.2; 17.6 | — |
| SECONDARY Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy |
0; 0 | — |
| SECONDARY Percentage of Participants in Follow up Trial With an Ectopic Pregnancy |
1.2; 0.6 | — |
| SECONDARY Percentage of Participants in Follow up Trial With a Clinical Pregnancy |
43.5; 38.6 | — |
| SECONDARY Percentage of Participants in Follow up Trial With a Vital Pregnancy |
39.9; 31.8 | — |
| SECONDARY Percentage of Participants in Follow up Trial With an Ongoing Pregnancy |
38.7; 30.7 | — |
Summary
To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), 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 Trial P05787 (NCT00696800), of which at least one embryo is thawed for use in a subsequent FTET cycle;
- Able and willing to give informed consent.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00702273). 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.