MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH) antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a single embryo was transferred at the blastocyst stage.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Menotropins

Criteria

Inclusion criteria:

• Informed Consent Documents signed prior to screening evaluations

• In good physical and mental health

• Pre-menopausal females 21-34 years of age

• Body mass index (BMI)18-25 kg/m2

• Eligible for intracytoplasmic sperm injection (ICSI)

• Unexplained infertility or partner with mild male factor infertility

• Infertility for at least 12 months before randomization

• Regular menstrual cycles of 24-35 days, presumed to be ovulatory

• Hysterosalpingography, hysteroscopy, or transvaginal ultrasound documenting a uterus consistent with expected normal function

• Transvaginal ultrasound documenting expected normal function of the ovaries

• Early follicular phase serum levels of FSH between 1 and 12 IU/L

• Early follicular phase total antral follicle (diameter 2-10 mm) count ≥ 10 for both ovaries combined

• Willing to accept transfer of one blastocyst in the fresh cycle

• Willing to undergo frozen embryo replacement cycles with transfer of one blastocyst per cycle within the first year after randomisation

Exclusion criteria:

• Known polycystic ovarian syndrome or known endometriosis stage I-IV

• Diagnosed as "poor responder" in a previous controlled ovarian stimulation (COS) cycle

• Severe ovarian hyperstimulation syndrome (OHSS)in a previous COS cycle

• History of recurrent miscarriage

• Current or past (12 months prior to randomization) abuse of alcohol or drugs, and/or current (last month) intake of more than 14 units of alcohol per week

• Current or past smoking habit of more than 10 cigarettes per day

• Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial

• Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue

• Previous participation in the trial

• Use of any non registered investigational drugs during 3 months before randomization