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Influence of Ovarian Stimulation With hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF


Phase 4
20 Years
38 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

Influence of Ovarian Stimulation With hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF


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).


Inclusion Criteria:



- Women with PCOS

Exclusion Criteria:

- Patients older than 38 years or with serum FSH level ≥12mIU/ml and a history of
ovarian surgery were excluded from the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the incidence of OHSS

Outcome Time Frame:

6 Months

Safety Issue:

No

Principal Investigator

Figen A Turkcapar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zekai Tahir Burak Women's Health Research and Training Hospital

Authority:

Turkey: Ministry of Health

Study ID:

ZTBIVF1

NCT ID:

NCT01365936

Start Date:

January 2008

Completion Date:

June 2008

Related Keywords:

  • Polycystic Ovary Syndrome
  • IVF
  • ICSI
  • OHSS
  • PCOS
  • recFSH
  • HMG
  • Polycystic Ovary Syndrome

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