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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Anovulation
• Interventions: Other: SET-diet plus clomiphene; Drug: Clomiphene citrate; Behavioral: Structured exercise program plus hypocaloric diet

• Registration Number: NCT01004068
• Lead Sponsor: University Magna Graecia

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-07-15
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Status Verified: 2009-11
• Last Update Submitted: 2010-11-02
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• PCOS
• Anovulation

Exclusion Criteria

• Major Medical Condition
• Severe Obesity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SET-diet plus clomiphene	SET-diet plus clomiphene	Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle
Clomiphene citrate	Clomiphene citrate	One month of observation followed by one-cycle of clomiphene citrate therapy
SET plus diet	Structured exercise program plus hypocaloric diet	Lifestyle modifications for two months.

Primary Outcome Measures

Name	Time	Method
Ovulation rate	three months

Secondary Outcome Measures

Name	Time	Method
Metabolic data	three months
Clinical data	three months

Trial Locations

Locations (1)

"Pugliese" Hospital; 🇮🇹 Catanzaro, Italy