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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01004068
Enrollment
96
Registered
2009-10-29
Start date
2008-02-29
Completion date
2009-10-31
Last updated
2010-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anovulation, Polycystic Ovary Syndrome

Keywords

Clomiphene, Diet, Exercise, Infertility, PCOS, Physical activity, Treatment

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.

Interventions

OTHERSET-diet plus clomiphene

Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate

DRUGClomiphene citrate

Clomiphene citrate at 150 mg daily for one cycle

BEHAVIORALStructured exercise program plus hypocaloric diet

SET plus diet

Sponsors

University Magna Graecia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* PCOS * Anovulation

Exclusion criteria

* Major Medical Condition * Severe Obesity

Design outcomes

Primary

MeasureTime frame
Ovulation ratethree months

Secondary

MeasureTime frame
Clinical datathree months
Metabolic datathree months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026