Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783) (Care)

Organon

Status: Completed

Conditions: Neonates; Pregnancy

Treatments: Biological: Human chorionic gonadotprophin (hCG).; Drug: Corifollitropin alpha (MK-8962, Org 36286) 100 ug; Drug: Corifollitropin alpha (MK-8962, Org 36286) 150 ug; Biological: Recombinant follicle stimulating hormone (recFSH); Drug: Triptorelin

Study type: Observational

Funder types: Industry

Identifiers

NCT00702520

P05783

MK-8962-010 (Other Identifier)

38834 (Other Identifier)

2005-000062-40 (EudraCT Number)

Details and patient eligibility

About

The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286) 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) is safe for pregnant participants and their offspring.

Full description

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who received one dose of corifollitropin alfa in Trial 38833;
• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
• Able and willing to give written informed consent.

Exclusion criteria

• None

Trial design

15 participants in 2 patient groups

Corifollitropin alpha 100 ug

Description:

In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily subcutaneous (SC) injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous luteinizing hormone (LH) and follicle stimulating hormone (FSH) was confirmed by estradiol (E2) and progesterone (P) measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recombinant follicle stimulating hormone (recFSH) injections (maximally 200 IU) up to and including the day of administration of human chorionic gonadotprophin (hCG). No study medications were administered in the present P05783 study (38834, NCT00702520).

Treatment:

Drug: Triptorelin

Biological: Recombinant follicle stimulating hormone (recFSH)

Drug: Corifollitropin alpha (MK-8962, Org 36286) 100 ug

Biological: Human chorionic gonadotprophin (hCG).

Corifollitropin alpha 150 ug

Description:

In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. No study medications were administered in the present P05783 study (38834, NCT00702520).

Treatment:

Drug: Triptorelin

Biological: Recombinant follicle stimulating hormone (recFSH)

Drug: Corifollitropin alpha (MK-8962, Org 36286) 150 ug

Biological: Human chorionic gonadotprophin (hCG).