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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome, Anovulation

Intervention / Treatment
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* Other: SET-diet plus clomiphene
* Drug: Clomiphene citrate
* Behavioral: Structured exercise program plus hypocaloric diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCOS Anovulation Exclusion Criteria: Major Medical Condition Severe Obesity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SET-diet plus clomiphene<br>Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle | Other: SET-diet plus clomiphene<br>* Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate<br>* Other names: CC;|
| Active Comparator: Clomiphene citrate<br>One month of observation followed by one-cycle of clomiphene citrate therapy | Drug: Clomiphene citrate<br>* Clomiphene citrate at 150 mg daily for one cycle<br>* Other names: CC;|
| Experimental: SET plus diet<br>Lifestyle modifications for two months. | Behavioral: Structured exercise program plus hypocaloric diet<br>* SET plus diet<br>* Other names: Lifestyle modifications;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rate |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical data |  | three months | 
| Metabolic data |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clomiphene, Diet, Exercise, Infertility, PCOS, Physical activity, Treatment