Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS

April 5, 2013 updated by: Stefano Palomba, University Magna Graecia

Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial

Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy.

The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients eligible will undergo baseline assessment consisting of antropometric, hormonal, and ultrasonographic assessments. Successively, patients enrolled will be allocated in three different strategies (strategy A, B, and C).

A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies: clomiphene followed by clomiphene plus metformin followed by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy C).

In all patients, the same regimen will be used to administered clomiphene, metformin, and gonadotropins.Both clomiphene and metformin will be administered at incremental doses in each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol.

During the study, the clinical and reproductive outcomes, and adverse experiences will be evaluated in each woman.

Study Type

Interventional

Enrollment (Anticipated)

552

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 Contact

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Recruiting
        • "Pugliese" Hospital
        • Contact:
          • Ingrid Tomaino, MD
          • Phone Number: +39 0961 883234
          • Email: zullo@unicz.it
        • Principal Investigator:
          • Francesco Orio, MD
        • Principal Investigator:
          • Achille Tolino, MD
        • Principal Investigator:
          • Pasquale Mastrantonio, MD
        • Principal Investigator:
          • Brian Dale, MD
        • Principal Investigator:
          • Ettore Cittadini, MD
        • Principal Investigator:
          • Andrea Riccardo Genazzani, MD
      • Catanzaro, Italy, 88100
        • Recruiting
        • Pugliese-Ciaccio 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

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Polycystic ovary syndrome (using ESHRE/ARSM 2004 criteria)

Exclusion Criteria:

  • Age <18 or >35 years
  • Severe obesity (BMI >35)
  • Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
  • Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
  • Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs
  • Previous use of ovulation induction agents
  • Intention to start a diet or a specific program of physical activity
  • No uterine bleeding after progesterone challenge test
  • Organic pelvic diseases
  • Previous pelvic surgery
  • Suspected peritoneal factor infertility
  • Tubal or male factor infertility or sub-fertility

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Strategy A
clomiphene followed by clomiphene plus metformin followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
Active Comparator: Strategy B
metformin followed by metformin plus clomiphene followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
Active Comparator: Strategy C
metformin plus clomiphene followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Multiple pregnancy rate
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ovulation rate
Time Frame: 15 months
15 months
Pregnancy rate
Time Frame: 15 months
15 months
Abortion rate
Time Frame: 15 months
15 months
Live-birth rate
Time Frame: 24 months
24 months
Adverse-events
Time Frame: 15
15

Collaborators and Investigators

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

Sponsor

University Magna Graecia

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, 2007

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 13, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2007

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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