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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Structured exercise training | |
| BEHAVIORAL | Hypocaloric 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.