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Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With PCOS

Primary Purpose

Polycystic Ovary Syndrome, Anovulation, Infertility

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Structured exercise training
Hypocaloric hyperproteic diet
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Structured exercise training program, Infertility, Menstrual cycle, PCOS, Treatment

Eligibility Criteria

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

Inclusion Criteria:

  • PCOS
  • Anovulatory infertility
  • Obesity (BMI >30)

Exclusion Criteria:

  • Age <18 or >35 years
  • Neoplastic, metabolic, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses
  • Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
  • Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs know to affect sex hormone levels, carbohydrate metabolism, or appetite
  • Organic pelvic diseases, previous pelvic surgery, suspected peritoneal factor infertility, tubal or male factor infertility or sub-fertility

Sites / Locations

  • "Pugliese" Hospital

Outcomes

Primary Outcome Measures

Pregnancy rate

Secondary Outcome Measures

Menstrual frequency
Abortion rate
Compliance

Full Information

First Posted
May 14, 2007
Last Updated
November 13, 2007
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT00473538
Brief Title
Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With PCOS
Official Title
Effects of Structured Exercise Program Versus Hypocaloric Hyperproteic Diet on the Reproductive Function in Obese Anovulatory Infertile Patients With Polycystic Ovary Syndrome: a 24-Week Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Lifestyle modifications are successfully employed in polycystic ovarian syndrome (PCOS) improving menstrual cycles and fertility. Unfortunately, the compliance over the time is very low. Recently, we have showed a high adherence to structured exercise training (SET) program in women with PCOS. The current study will be aimed to compare the efficacy of the SET program with a diet program on the reproductive function in obese anovulatory infertile PCOS patients.
Detailed Description
Forty obese anovulatory infertile PCOS patients who wish to conceive will be allocated in two study-groups according to their desire: structured exercise training (SET) group (n. 20) will undergo a SET program, whereas diet group (n. 20) will undertake a hypocaloric hyperproteic diet. The duration of the study will be of 24 weeks. At baseline, after 12 and 24 weeks clinical, endocrine and metabolic evaluations will be performed in each patient and all reproductive events obtained throughout the study will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Anovulation, Infertility
Keywords
Structured exercise training program, Infertility, Menstrual cycle, PCOS, Treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Structured exercise training
Intervention Type
Behavioral
Intervention Name(s)
Hypocaloric hyperproteic diet
Primary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
six months
Secondary Outcome Measure Information:
Title
Menstrual frequency
Time Frame
six months
Title
Abortion rate
Time Frame
six months
Title
Compliance
Time Frame
six 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 Anovulatory infertility Obesity (BMI >30) Exclusion Criteria: Age <18 or >35 years Neoplastic, metabolic, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs know to affect sex hormone levels, carbohydrate metabolism, or appetite Organic pelvic diseases, previous pelvic surgery, suspected peritoneal factor infertility, tubal or male factor infertility or sub-fertility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Orio, MD
Organizational Affiliation
Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II" of Naples, and Chair of Endocrinology, University "Parthenope", of Naples
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
8567797
Citation
Clark AM, Ledger W, Galletly C, Tomlinson L, Blaney F, Wang X, Norman RJ. Weight loss results in significant improvement in pregnancy and ovulation rates in anovulatory obese women. Hum Reprod. 1995 Oct;10(10):2705-12. doi: 10.1093/oxfordjournals.humrep.a135772.
Results Reference
background
PubMed Identifier
15140873
Citation
Norman RJ, Noakes M, Wu R, Davies MJ, Moran L, Wang JX. Improving reproductive performance in overweight/obese women with effective weight management. Hum Reprod Update. 2004 May-Jun;10(3):267-80. doi: 10.1093/humupd/dmh018.
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
derived

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Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With PCOS

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