IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS

May 8, 2017 updated by: Mohamed Sayed Abdelhafez

In Vitro Fertilization Versus Gonadotropin Therapy in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Women will be randomly divided into two groups; IVF group and gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.

Study Type

Interventional

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

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35111
        • Fertility Care Unit (FCU) in Mansoura University Hospital
      • Mansoura, Dakahlia, Egypt
        • Private fertility care centers

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Infertile women with PCOS as defined by the Rotterdam criteria.
  • CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria:

  • Age < 20 or > 35 years.
  • Presence of any infertility factor other than anovulatory PCOS.
  • Previous history of ovarian surgery or surgical removal of one ovary.
  • Previous exposure to cytotoxic drugs or pelvic irradiation.
  • Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
  • Metabolic or hormonal abnormalities.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IVF group
Women will undergo one full IVF cycle
Procedure: IVF
Women will undergo one IVF cycle
Other Names:
  • Intracytoplasmic sperm injection (ICSI)
Active Comparator: Gonadotropin group
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.
Drug: Gonadotropin
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol
Other Names:
  • Human Menopausal Gonadotropin (HMG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: 9 months
Number of live births divided by the number of women
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage rate
Time Frame: 12 weeks gestational age
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
12 weeks gestational age
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Time Frame: Within 9 days of final triggering of oocyte maturation
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Within 9 days of final triggering of oocyte maturation
Clinical pregnancy rate
Time Frame: 6-8 weeks gestational age
Number of clinical pregnancies divided by the number of women
6-8 weeks gestational age
Multifetal pregnancy rate
Time Frame: 12 weeks gestational age
Number of multifetal pregnancies divided by the number of clinical pregnancies
12 weeks gestational age

Collaborators and Investigators

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

Sponsor

Mohamed Sayed Abdelhafez

Investigators

  • Principal Investigator: Ahmed Gibreel, Dr, Mansoura 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

January 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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