Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

Organon

Status: Completed

Conditions: In Vitro Fertilization

Treatments: Biological: progesterone; Drug: placebo-recFSH (follitropin alfa); Drug: human chorion gonadatropin (hCG); Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Biological: recFSH (follitropin alfa); Biological: open-label recFSH; Drug: corifollitropin alfa; Drug: placebo-corifollitropin alfa

Study type: Observational

Funder types: Industry

Identifiers

NCT00702546

MK-8962-004 (Other Identifier)

2006-003813-42 (EudraCT Number)

P05711

107015 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

102 participants in 2 patient groups

Corifollitropin alfa 100 μg

Description:

In follow-up study, no medication or investigational product was administered. But in base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.

Treatment:

Drug: human chorion gonadatropin (hCG)

Biological: progesterone

Drug: corifollitropin alfa

Drug: placebo-recFSH (follitropin alfa)

Biological: open-label recFSH

Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix

recFSH 150 IU

Description:

In this follow-up study, no medication or investigational product was administered. However, in base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Treatment:

Drug: human chorion gonadatropin (hCG)

Biological: progesterone

Biological: recFSH (follitropin alfa)

Drug: placebo-corifollitropin alfa

Biological: open-label recFSH

Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix