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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004068
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : November 3, 2010
Sponsor:
Information provided by:
University Magna Graecia

Tracking Information
First Submitted Date  ICMJE July 15, 2009
First Posted Date  ICMJE October 29, 2009
Last Update Posted Date November 3, 2010
Study Start Date  ICMJE February 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Ovulation rate [ Time Frame: three months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • Clinical data [ Time Frame: three months ]
  • Metabolic data [ Time Frame: three months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Ovary Syndrome
  • Anovulation
Intervention  ICMJE
  • Other: SET-diet plus clomiphene
    Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate
    Other Names:
    • Lifestyle modification
    • CC
  • Drug: Clomiphene citrate
    Clomiphene citrate at 150 mg daily for one cycle
    Other Name: CC
  • Behavioral: Structured exercise program plus hypocaloric diet
    SET plus diet
    Other Name: Lifestyle modifications
Study Arms  ICMJE
  • Experimental: SET-diet plus clomiphene
    Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle
    Intervention: Other: SET-diet plus clomiphene
  • Active Comparator: Clomiphene citrate
    One month of observation followed by one-cycle of clomiphene citrate therapy
    Intervention: Drug: Clomiphene citrate
  • Experimental: SET plus diet
    Lifestyle modifications for two months.
    Intervention: Behavioral: Structured exercise program plus hypocaloric diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2009)
96
Original Actual Enrollment  ICMJE
 (submitted: October 28, 2009)
60
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • PCOS
  • Anovulation

Exclusion Criteria:

  • Major Medical Condition
  • Severe Obesity
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004068
Other Study ID Numbers  ICMJE 06/2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Department of Obstetrics and Gynecology, University Magna Graecia of Catanzaro
Study Sponsor  ICMJE University Magna Graecia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefano Palomba, MD University Magna Graecia
PRS Account University Magna Graecia
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP