hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      There have been some controversies regarding the use of preparations with LH activity in
      patients with polycystic ovary syndrome (PCOS) who have high endogenous LH activity. In this
      research we aimed to compare urinary menotrophin versus recombinant FSH (rFSH) with respect
      to the prevention of OHSS
    

Detailed description: 
      Polycystic ovary syndrome was diagnosed according to the Rotterdam criteria. Patients older
      than 38 years or with serum FSH level ≥12mIU/ml and a history of ovarian surgery were
      excluded from the study. All of our patients were given combined oral contraceptive (Yasmin)
      prior to ovulation induction cycles. Leuprolide Acetate (Lucrin daily; Abbott, Istanbul)
      therapy was started in mid-luteal phase to induce pituitary down regulation, and was
      initiated at a dose of 1.0 mg SC daily until pituitary down-regulation was established. The
      leuprolide acetate dose was then reduced to 0.5 mg daily until the day of human chorionic
      gonadotropin (hCG) administration. After GnRH analogue suppression was achieved, the patients
      were randomized using block randomization (block of two) to stimulation with hMG (Menogon;
      Ferring Pharmaceuticals. Istanbul) or rFSH (Gonal-F; Serono Istanbul). Starting dose was
      150IU for the first 3 days of stimulation, after which daily dosing was determined
      individually. Serial Estrodiol (E2) levels and two-dimensional follicle measurements by
      transvaginal ultrasonography (LOGIC 200 PRO, General Electric, Korea) were performed until at
      least two dominant follicles reached dimensions of 18 mm or greater in diameter. Human
      chorionic gonadotropin (Pregnyl, Organon, 10,000 IU- IM) was then administered, followed by
      transvaginal oocyte retrieval 36 hours later. The criteria of coasting in our institute were
      serum E2 >3600 pg/ml and multiple intermediate follicle. During coasting period, gonadotropin
      was withheld, but leuprolide acetate was continued at 0.5mg/d. ICSI was performed for all the
      patients. Fertilization was assessed at 20h (±1h), and embryo quality was assessed at 28, 44,
      and 68h (±1h) after oocyte retrieval. A top- quality embryo was defined as four to five cells
      on day 2, seven or more cells on day 3, and no multinucleation. Vaginal progesterone gel 90
      mg/day 8% (Crinone;Serono) for luteal support was given from the oocyte retrieval until the
      clinical pregnancy (9-10 weeks of gestation) or negative serum βhCG test (13-15 days after
      embryo transfer).
    

Intervention name(s): HMG; rFSH
Intervention type(s): Drug; Drug
Intervention description(s): In this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.; Patients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
Other intervention name(s): Menotrophin
Intervention MeSH terms: Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF; ICSI; OHSS; PCOS; recFSH; HMG