In Vitro Fertilization Outcomes of Two Treatment Protocols in Women With Polycystic Ovary Syndrome (PCOS and ivf)

February 1, 2012 updated by: Bulent Haydardedeoglu

IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS

Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone (GnRH) agonist and GnRH Antagonist fixed protocol.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Women with PCOS undergoing IVF/ICSI cycles will be evaluated by two different protocols. One arm of the study includes oral contraceptive plus GnRH agonist protocol with 150 IU FSH (standard dose) and second arm includes oral contraceptive plus GnRH Antagonist with 150 IU FSH dose and fixed 6th day starting of GnRH Antagonist.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

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
      • Adana, Turkey, 01120
        • Bulent Haydardedeoglu

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 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS women undergoing ICSI cycles
  • All women will be administered 150 IU rec FSH

Exclusion Criteria:

  • Women having other endocrinopathies
  • women older than 35
  • third IVF/ICSI cycles
  • previous and current use of metformin

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

  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: GnRH Agonist
oral contraceptive pill and GnRH Agonist IVF/ICSI cycle
Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle
150 IU FSH dose and OCP plus GnRH Agonist (long luteal) IVF/ICSI cycle and 150 IU FSH dose and OCP plus GnRH Antagonist (Fixed protocol) IVF/ICSI Cycle
ACTIVE_COMPARATOR: GnRH Agonist Arm
Oral contraceptive pill and day 21 GnRH agonist began, Day 3 of menstruation 150 IU FSH will be started. If 3 or more follicle reach >17 mm hCG will be administered.
Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle
150 IU FSH dose and OCP plus GnRH Agonist (long luteal) IVF/ICSI cycle and 150 IU FSH dose and OCP plus GnRH Antagonist (Fixed protocol) IVF/ICSI Cycle
Other: GnRH Antagonist
GnRH Antagonist cycle; 150 IU FSH and sixth day Antagonist will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rates
Time Frame: March 2009 to June 2011
Ongoing pregnancy rates measured in OCP plus GnRH Agonist and OCP plus GnRH Antagonist cycles in women with PCOS
March 2009 to June 2011
clinical pregnancy rate
Time Frame: from march 2009 to july 2011
To evaluate the clinical pregnancy rates of both study arms
from march 2009 to july 2011
Total gonadotropin use
Time Frame: From march 2009 to June 2011
Total gonadotropin use of both study arms
From march 2009 to June 2011

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OHSS rates
Time Frame: from march 2009 to july 2011
OHSS rates in both study groups
from march 2009 to july 2011
Total ongoing pregnancy rate
Time Frame: from march 2009 to june 2011
Total ongoing pregnacy rates of per protocol group including freezing-thawing embryo transfer cycles.
from march 2009 to june 2011

Collaborators and Investigators

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

Sponsor

Bulent Haydardedeoglu

Investigators

  • Study Chair: Bulent Haydardedeoglu, M.D., Baskent University

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

March 1, 2009

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

May 12, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (ESTIMATE)

May 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH532008
  • KA04/104 (OTHER: Baskent University KA04/104)

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.

Subscribe