Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

Organon

Status: Completed

Conditions: Neonates; Pregnancy

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00703014

P05712

2004-004772-36 (EudraCT Number)

38821 (Other Identifier)

MK-8962-005 (Other Identifier)

Details and patient eligibility

About

The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).

Full description

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.

Enrollment: 541 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who received at least one dose of either Corifollitropin Alfa or

Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);

• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Base Trial P05787 (NCT00696800);
• Able and willing to give written informed consent.

Exclusion criteria

• None

Trial design

541 participants in 2 patient groups

Mothers Corifollitropin Alfa 150 µg

Description:

Participants from the Base Trial P05787 who received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation 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); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.

Treatment:

Drug: Corifollitropin Alfa 150 μg

Drug: Placebo for RecFSH/Follitropin beta

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

Biological: Progesterone

Biological: hCG

Drug: Ganirelix

Mothers recFSH 200 IU

Description:

Participants from the Base Trial P05787 who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation 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 from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and 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 Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.

Treatment:

Drug: Placebo for Corifollitropin Alfa

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

Biological: Progesterone

Biological: hCG

Drug: Ganirelix

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