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

NCT ID: NCT00473538

Last Updated: 2007-11-14

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome Anovulation Infertility

Keywords

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Structured exercise training program Infertility Menstrual cycle PCOS Treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Structured exercise training

Intervention Type BEHAVIORAL

Hypocaloric hyperproteic diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
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

Principal Investigators

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Stefano Palomba, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Francesco Orio, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II" of Naples, and Chair of Endocrinology, University "Parthenope", of Naples

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)

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.

Reference Type BACKGROUND
PMID: 8567797 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15140873 (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 DERIVED
PMID: 18158291 (View on PubMed)

Other Identifiers

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01/2004

Identifier Type: -

Identifier Source: org_study_id