Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)

November 2, 2010 updated by: University Magna Graecia

Does Short-term Structured Exercise Training Program Plus Diet Intervention Improve Ovarian Sensitivity to Clomiphene Citrate in Polycystic Ovary Syndrome Patients (PCOS)? A Prospective Randomized Controlled Study

Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC. Structured exercise training (SET) and diet has been successfully employed to restore ovarian function and to improve reproductive outcomes in obese and overweight women with PCOS. The current study was aimed to test the hypothesis that a short-term SET program plus diet intervention can improve the ovarian response to CC in CC-resistant PCOS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ninety-six PCOS patients considered CC-resistant because not responsive to 150 mg daily of CC were randomized in three arms (group A, B, and C). Group A underwent SET program plus hypocaloric diet for two months, group B had one month of observation followed by one-cycle of CC therapy, and group C underwent SET program plus hypocaloric diet for two months and received one-cycle of CC for one cycle. CC was always given at the maximal dose previously used. Clinical, hormonal and metabolic data were assessed at baseline and after intervention. Ovulation was monitored by ultrasound and confirmed by plasma progesterone assay.

Study Type

Interventional

Enrollment (Actual)

96

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

  • Italy
      • Catanzaro, Italy, 88100
        • "Pugliese" 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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS
  • Anovulation

Exclusion Criteria:

  • Major Medical Condition
  • Severe Obesity

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
Experimental: SET-diet plus clomiphene
Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle
Other: SET-diet plus clomiphene
Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate
Other Names:
  • CC
  • Lifestyle modification
Active Comparator: Clomiphene citrate
One month of observation followed by one-cycle of clomiphene citrate therapy
Drug: Clomiphene citrate
Clomiphene citrate at 150 mg daily for one cycle
Other Names:
  • CC
Experimental: SET plus diet
Lifestyle modifications for two months.
Behavioral: Structured exercise program plus hypocaloric diet
SET plus diet
Other Names:
  • Lifestyle modifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ovulation rate
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical data
Time Frame: three months
three months
Metabolic data
Time Frame: three months
three months

Collaborators and Investigators

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

Sponsor

University Magna Graecia

Investigators

  • Principal Investigator: Stefano Palomba, MD, 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

February 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

July 15, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

November 3, 2010

Last Update Submitted That Met QC Criteria

November 2, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/2009

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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