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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004773-28-FI

Enrollment

Unknown

Registered

2006-04-10

Start date

2006-06-30

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: corifollitropin alfa Product Code: Org 36286 Pharmaceutical Form: Solution for injection INN or Proposed INN: corifollitropin alfa

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Belgium, Czech Republic, Finland, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026