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

Primary Purpose

Polycystic Ovary Syndrome, Anovulation

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
SET-diet plus clomiphene
Clomiphene citrate
Structured exercise program plus hypocaloric diet
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Clomiphene, Diet, Exercise, Infertility, PCOS, Physical activity, Treatment

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • PCOS
  • Anovulation

Exclusion Criteria:

  • Major Medical Condition
  • Severe Obesity

Sites / Locations

  • "Pugliese" Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

SET-diet plus clomiphene

Clomiphene citrate

SET plus diet

Arm Description

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

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

Lifestyle modifications for two months.

Outcomes

Primary Outcome Measures

Ovulation rate

Secondary Outcome Measures

Clinical data
Metabolic data

Full Information

First Posted
July 15, 2009
Last Updated
November 2, 2010
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT01004068
Brief Title
Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Anovulation
Keywords
Clomiphene, Diet, Exercise, Infertility, PCOS, Physical activity, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SET-diet plus clomiphene
Arm Type
Experimental
Arm Description
Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle
Arm Title
Clomiphene citrate
Arm Type
Active Comparator
Arm Description
One month of observation followed by one-cycle of clomiphene citrate therapy
Arm Title
SET plus diet
Arm Type
Experimental
Arm Description
Lifestyle modifications for two months.
Intervention Type
Other
Intervention Name(s)
SET-diet plus clomiphene
Other Intervention Name(s)
Lifestyle modification, CC
Intervention Description
Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate
Other Intervention Name(s)
CC
Intervention Description
Clomiphene citrate at 150 mg daily for one cycle
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise program plus hypocaloric diet
Other Intervention Name(s)
Lifestyle modifications
Intervention Description
SET plus diet
Primary Outcome Measure Information:
Title
Ovulation rate
Time Frame
three months
Secondary Outcome Measure Information:
Title
Clinical data
Time Frame
three months
Title
Metabolic data
Time Frame
three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PCOS Anovulation Exclusion Criteria: Major Medical Condition Severe Obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
Organizational Affiliation
University Magna Graecia
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Pugliese" Hospital
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17264174
Citation
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.
Results Reference
background
PubMed Identifier
18158291
Citation
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.
Results Reference
background
PubMed Identifier
20858697
Citation
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.
Results Reference
result

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

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