Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

Organon

Status: Completed

Conditions: In Vitro Fertilization

Treatments: Drug: Placebo for RecFSH/Follitropin beta; Drug: Placebo for Corifollitropin Alfa; Biological: hCG; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Drug: Ganirelix; Biological: Progesterone; Drug: 150 µg Corifollitropin Alfa; Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7)

Study type: Observational

Funder types: Industry

Identifiers

NCT00702273

MK-8962-009 (Other Identifier)

38831 (Other Identifier)

P05716

2004-004773-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment group.

Enrollment: 344 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

344 participants in 2 patient groups

150 µg Corifollitropin Alfa

Description:

Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (Org 36286) on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.

Treatment:

Drug: 150 µg Corifollitropin Alfa

Biological: Progesterone

Drug: Ganirelix

Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)

Biological: hCG

Drug: Placebo for RecFSH/Follitropin beta

200 IU RecFSH

Description:

Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.

Treatment:

Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7)

Biological: Progesterone

Drug: Ganirelix

Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)

Biological: hCG

Drug: Placebo for Corifollitropin Alfa