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

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-01

Study Completion Date

2008-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy Neonates

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Corifollitropin alpha 100 ug

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).

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

Intervention Type DRUG

Subcutaneous administration of corifollitropin alpha at a dose of 100 ug

Triptorelin

Intervention Type DRUG

Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).

Recombinant follicle stimulating hormone (recFSH)

Intervention Type BIOLOGICAL

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.

Human chorionic gonadotprophin (hCG).

Intervention Type BIOLOGICAL

HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.

Corifollitropin alpha 150 ug

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).

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

Intervention Type DRUG

Subcutaneous administration of corifollitropin alpha at a dose of 150 ug

Triptorelin

Intervention Type DRUG

Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).

Recombinant follicle stimulating hormone (recFSH)

Intervention Type BIOLOGICAL

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.

Human chorionic gonadotprophin (hCG).

Intervention Type BIOLOGICAL

HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.

Interventions

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

Subcutaneous administration of corifollitropin alpha at a dose of 100 ug

Intervention Type DRUG

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

Subcutaneous administration of corifollitropin alpha at a dose of 150 ug

Intervention Type DRUG

Triptorelin

Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).

Intervention Type DRUG

Recombinant follicle stimulating hormone (recFSH)

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.

Intervention Type BIOLOGICAL

Human chorionic gonadotprophin (hCG).

HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.