Status:
COMPLETED
MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
21-34 years
Phase:
PHASE3
Brief 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 h...
Detailed Description
This was a randomized, open-label, assessor-blind, parallel groups, multicentre trial comparing the efficacy of highly purified menotrophin (MENOPUR; Ferring) and recombinant FSH (PUREGON/FOLLISTIM; M...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
749 Patients enrolled
Trial Details
Trial ID
NCT00884221
Start Date
July 1 2009
End Date
January 1 2011
Last Update
April 20 2012
Active Locations (25)
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1
ERASME Hospital
Anderlecht, Belgium
2
UZ Brussel
Brussels, Belgium
3
UZ Antwerpen
Edegem, Belgium
4
UZ Gent
Ghent, Belgium