Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With PCOS - Full Text View

Purpose

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.

Condition	Intervention	Phase
Polycystic Ovary Syndrome Anovulation Infertility	Behavioral: Structured exercise training Behavioral: Hypocaloric hyperproteic diet	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:

Pregnancy rate [ Time Frame: six months ]

Secondary Outcome Measures:

Menstrual frequency [ Time Frame: six months ]
Abortion rate [ Time Frame: six months ]
Compliance [ Time Frame: six months ]

Enrollment:	40
Study Start Date:	January 2004
Estimated Study Completion Date:	August 2006

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473538

Locations

Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100

Sponsors and Collaborators

University Magna Graecia

Investigators

Principal Investigator:	Stefano Palomba, MD	Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Principal Investigator:	Francesco Orio, MD	Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II" of Naples, and Chair of Endocrinology, University "Parthenope", of Naples

More Information

Publications:

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.

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.

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. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00473538 History of Changes
Other Study ID Numbers:	01/2004
Study First Received:	May 14, 2007
Last Updated:	November 13, 2007
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:

Structured exercise training program
Infertility
Menstrual cycle
PCOS
Treatment

Additional relevant MeSH terms:

Anovulation
Infertility
Polycystic Ovary Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

Gonadal Disorders
Endocrine System Diseases
Genital Diseases, Male
Ovarian Cysts
Cysts
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013