MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

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.
    

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; MSD/Merck) in women undergoing controlled ovarian stimulation following a
      GnRH antagonist protocol.

      The use of oral contraceptives for programming of the trial cycle was prohibited. On day 2-3
      of the menstrual cycle, participants were randomized in a 1:1 fashion to treatment with
      either highly purified menotrophin (MENOPUR) or recombinant FSH, and stimulation was
      initiated.

      The gonadotrophin starting dose was 150 international units (IU) daily for the first 5 days.
      Hereafter, the participants were seen on stimulation day 6 and subsequently at least every 2
      days when a transvaginal ultrasound was made to monitor response to stimulation. From
      stimulation day 6 and onwards, dosing could be adjusted according to individual patient
      response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. 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. Coasting was prohibited.

      The GnRH antagonist (ORGALUTRAN/GANIRELIX ACETATE INJECTION; MSD/Merck) was initiated on
      stimulation day 6 at a daily dose of 0.25 mg and continued throughout the gonadotrophin
      treatment period. A single injection of recombinant human chorionic gonadotrophin (hCG) 250
      µg (OVITRELLE/OVIDREL; Merck Serono/EMD Serono) was administered to induce final follicular
      maturation as soon as 3 follicles of ≥ 17 mm were observed; i.e., the day of reaching the hCG
      criterion or the next day. Oocyte retrieval took place 36h (± 2h) after hCG administration.
      Oocytes were inseminated using partner sperm by intracytoplasmic sperm injection (ICSI) 4h (±
      1h) after retrieval. Oocyte, embryo and blastocyst quality was assessed daily from oocyte
      retrieval till 5 days after. On day 5 after oocyte retrieval, a single blastocyst of the best
      quality available was transferred and all remaining blastocysts were frozen. Vaginal
      progesterone capsules (UTROGESTAN; Seid) 600 mg/day were provided for luteal phase support
      from the day after oocyte retrieval till the day of the beta human chorionic gonadotrophin
      (βhCG) test (13-15 days after embryo transfer); prolonged luteal phase support beyond this
      time point was not allowed. Clinical pregnancy was confirmed by transvaginal ultrasound 5-6
      weeks after embryo transfer and ongoing pregnancy was confirmed by transvaginal ultrasound
      10-11 weeks after embryo transfer. Post-trial follow-up included pregnancy outcome (e.g. live
      birth) and neonatal health from the fresh trial cycle. Additional post-trial activities
      included follow-up of frozen embryo replacement cycles initiated within 1 year after the
      participant's randomization date.
    

Intervention name(s): Highly purified menotrophin; Recombinant FSH
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): HP-hMG; MENOPUR; Follitrophin-beta; PUREGON; FOLLISTIM
Intervention MeSH terms: Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment