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

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01004068
First received: July 15, 2009
Last updated: November 2, 2010
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Polycystic Ovary Syndrome
Anovulation
Other: SET-diet plus clomiphene
Drug: Clomiphene citrate
Behavioral: Structured exercise program plus hypocaloric diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Ovulation rate [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical data [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Metabolic data [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: February 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Lifestyle modification
  • CC
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 Name: CC
Experimental: SET plus diet
Lifestyle modifications for two months.
Behavioral: Structured exercise program plus hypocaloric diet
SET plus diet
Other Name: Lifestyle modifications

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCOS
  • Anovulation

Exclusion Criteria:

  • Major Medical Condition
  • Severe Obesity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004068

Locations
Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Stefano Palomba, MD University Magna Graecia
  More Information

Publications:
Responsible Party: Department of Obstetrics and Gynecology, University Magna Graecia of Catanzaro
ClinicalTrials.gov Identifier: NCT01004068     History of Changes
Other Study ID Numbers: 06/2009
Study First Received: July 15, 2009
Last Updated: November 2, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:
Clomiphene
Diet
Exercise
Infertility
PCOS
Physical activity
Treatment

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Anovulation
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female

ClinicalTrials.gov processed this record on September 29, 2014