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hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF

Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01365936
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
5
Duration (Months)
16
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 4

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Influence of Ovarian Stimulation With hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: menotrophin

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.

Drug: HMG
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.
Other Names:
  • Menotrophin

    		•
    Active Comparator: recombinant FSH

    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.

    Drug: rFSH
    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.

    Outcome Measures

    Primary Outcome Measures

    1. the incidence of OHSS [6 Months]

    2. peak serum E2 levels [6 months]

    Secondary Outcome Measures

    1. the need of coasting, [6 months]

    2. number of intermediate follicles [6 months]

    3. fertilization rate [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zekai Tahir Burak women's research and Training Hospital Ankara Turkey

    Sponsors and Collaborators

    • Zekai Tahir Burak Women's Health Research and Education Hospital

    Investigators

    • Principal Investigator: Figen A Turkcapar, MD, Zekai Tahir Burak Women's Health Research and Training Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Figen Turkcapar, MD, Zekai Tahir Burak Women's Health Research and Education Hospital
    ClinicalTrials.gov Identifier:
    NCT01365936
    Other Study ID Numbers:
    • ZTBIVF1
    First Posted:
    Jun 3, 2011
    Last Update Posted:
    Mar 29, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Figen Turkcapar, MD, Zekai Tahir Burak Women's Health Research and Education Hospital
    IVF
    ICSI
    OHSS
    PCOS
    recFSH
    HMG
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Menotropins

    Study Results

    No Results Posted as of Mar 29, 2012