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

March 28, 2012 updated by: Figen Turkcapar, Zekai Tahir Burak Women's Health Research and Education Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Zekai Tahir Burak women's research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of OHSS
Time Frame: 6 Months
6 Months
peak serum E2 levels
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the need of coasting,
Time Frame: 6 months
6 months
number of intermediate follicles
Time Frame: 6 months
6 months
fertilization rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (ESTIMATE)

June 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZTBIVF1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Clinical Trials on HMG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe