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

NCT ID: NCT01004068

Last Updated: 2010-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-10-31

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.

Conditions

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Polycystic Ovary Syndrome Anovulation

Keywords

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Clomiphene Diet Exercise Infertility PCOS Physical activity Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SET-diet plus clomiphene

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

Group Type EXPERIMENTAL

SET-diet plus clomiphene

Intervention Type OTHER

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

Clomiphene citrate

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

Group Type ACTIVE_COMPARATOR

Clomiphene citrate

Intervention Type DRUG

Clomiphene citrate at 150 mg daily for one cycle

SET plus diet

Lifestyle modifications for two months.

Group Type EXPERIMENTAL

Structured exercise program plus hypocaloric diet

Intervention Type BEHAVIORAL

SET plus diet

Interventions

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SET-diet plus clomiphene

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

Intervention Type OTHER

Clomiphene citrate

Clomiphene citrate at 150 mg daily for one cycle

Intervention Type DRUG

Structured exercise program plus hypocaloric diet

SET plus diet

Intervention Type BEHAVIORAL

Other Intervention Names

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Lifestyle modification CC CC Lifestyle modifications

Eligibility Criteria

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Inclusion Criteria

* PCOS
* Anovulation

Exclusion Criteria

* Major Medical Condition
* Severe Obesity
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Responsible Party

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University Magna Graecia of Catanzaro

Principal Investigators

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Stefano Palomba, MD

Role: PRINCIPAL_INVESTIGATOR

University Magna Graecia

Locations

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"Pugliese" Hospital

Catanzaro, , Italy

Site Status

Countries

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Italy

References

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Vigorito C, Giallauria F, Palomba S, Cascella T, Manguso F, Lucci R, De Lorenzo A, Tafuri D, Lombardi G, Colao A, Orio F. Beneficial effects of a three-month structured exercise training program on cardiopulmonary functional capacity in young women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Apr;92(4):1379-84. doi: 10.1210/jc.2006-2794. Epub 2007 Jan 30.

Reference Type BACKGROUND
PMID: 17264174 (View on PubMed)

Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.

Reference Type BACKGROUND
PMID: 18158291 (View on PubMed)

Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.

Reference Type RESULT
PMID: 20858697 (View on PubMed)

Other Identifiers

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06/2009

Identifier Type: -

Identifier Source: org_study_id