Follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles after cryopreservation of embryos in clinical trial 38819

Conditions: Controlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) program
MedDRA version: 7.1Level: LLTClassification code 10017399

Registration Number: EUCTR2004-004773-28-CZ

Lead Sponsor: V Organon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1. Subjects from whom embryos have been cryopreserved in Trial 38819 of which at least one embryo is thawed for use in a subsequent FTET cycle;
2. Able and willing to give informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

None

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved in Trial 38819, in order to estimate the cumulative pregnancy rate for each treatment group.;Secondary Objective: ;Primary end point(s): Cumulative ongoing pregnancy rate; the cumulative ongoing pregnancy rate is the percentage of subjects who started controlled ovarian stimulation treatment in Trial 38819 and have an ongoing pregnancy either immediately after embryo transfer in Trial 38819 or after one or more frozen-thawed embryo transfer cycles following cryopreservation.

Secondary Outcome Measures