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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Figen Turkcapar, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01365936
First received: May 31, 2011
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
Drug: HMG
Drug: rFSH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Ovarian Stimulation With hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • the incidence of OHSS [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • peak serum E2 levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the need of coasting, [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • number of intermediate follicles [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • fertilization rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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).

  Eligibility

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01365936

Locations
Turkey
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
  More Information

No publications provided

Responsible Party: Figen Turkcapar, MD, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01365936     History of Changes
Other Study ID Numbers: ZTBIVF1
Study First Received: May 31, 2011
Last Updated: March 28, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
IVF
ICSI
OHSS
PCOS
recFSH
HMG

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Adnexal Diseases
Cysts
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases

ClinicalTrials.gov processed this record on November 19, 2014