MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Intervention: Highly purified menotrophin; Recombinant FSH
Intervention description: The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion.; The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion.
Intervention MeSH terms: Menotropins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 749.0
Sex: Female
Minimum age: 21 Years
Maximum age: 34 Years
Healthy volunteers: No

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.
    

Eligibility 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