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

University Magna Graecia

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome; Anovulation

Treatments: Behavioral: Structured exercise program plus hypocaloric diet; Drug: Clomiphene citrate; Other: SET-diet plus clomiphene

Study type: Interventional

Funder types: Other

Identifiers

NCT01004068

06/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PCOS
• Anovulation

Exclusion criteria

• Major Medical Condition
• Severe Obesity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

SET-diet plus clomiphene

Experimental group

Description:

Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle

Treatment:

Other: SET-diet plus clomiphene

Clomiphene citrate

Active Comparator group

Description:

One month of observation followed by one-cycle of clomiphene citrate therapy

Treatment:

Drug: Clomiphene citrate

SET plus diet

Experimental group

Description:

Lifestyle modifications for two months.

Treatment:

Behavioral: Structured exercise program plus hypocaloric diet