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

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Infertility Polycystic Ovary Syndrome

Drug Information available for: Clomiphene citrate Clomiphene Sodium citrate

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:

Ovulation rate [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical data [ Time Frame: three months ] [ Designated as safety issue: No ]
Metabolic data [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	February 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: CC
Experimental: SET plus diet Lifestyle modifications for two months.	Behavioral: Structured exercise program plus hypocaloric diet SET plus diet Other Name: Lifestyle modifications

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PCOS
Anovulation

Exclusion Criteria:

Major Medical Condition
Severe Obesity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004068

Locations

Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100

Sponsors and Collaborators

University Magna Graecia

Investigators

Principal Investigator:

Stefano Palomba, MD

University Magna Graecia

More Information

Publications:

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. Epub 2010 Sep 21.

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. Epub 2007 Jan 30.

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. Epub 2007 Dec 23.

Responsible Party:	Department of Obstetrics and Gynecology, University Magna Graecia of Catanzaro
ClinicalTrials.gov Identifier:	NCT01004068 History of Changes
Other Study ID Numbers:	06/2009
Study First Received:	July 15, 2009
Last Updated:	November 2, 2010
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:

Clomiphene
Diet
Exercise
Infertility

PCOS
Physical activity
Treatment

Additional relevant MeSH terms:

Anovulation
Polycystic Ovary Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Ovarian Cysts
Cysts
Neoplasms
Citric Acid
Clomiphene
Anticoagulants
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on May 23, 2013