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

Sponsor

University Magna Graecia (Other)

Overall Status

Completed

CT.gov ID

NCT01004068

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

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: 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 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

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:

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