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Trials / Completed

CompletedNCT00473538

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

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.

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University Magna Graecia · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStructured exercise training
BEHAVIORALHypocaloric hyperproteic diet

Timeline

Start date
2004-01-01
Completion
2006-08-01
First posted
2007-05-15
Last updated
2007-11-14

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00473538. Inclusion in this directory is not an endorsement.

Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With P (NCT00473538) · Clinical Trials Directory