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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Anovulation; Infertility

• Registration Number: NCT00473538
• Lead Sponsor: University Magna Graecia

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.

Study Timeline

• Study Start: 2004-01
• Study Completion: 2006-08
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-15
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-13
• Last Update Posted: 2007-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	six months

Secondary Outcome Measures

Name	Time	Method
Menstrual frequency	six months
Abortion rate	six months
Compliance	six months

Trial Locations

Locations (1)

"Pugliese" Hospital; 🇮🇹 Catanzaro, Italy