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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.


Phase 4
18 Years
35 Years
Not Enrolling
Female
Polycystic Ovary Syndrome, Anovulation, Infertility

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pregnancy rate

Outcome Time Frame:

six months

Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Italy: The Italian Medicines Agency

Study ID:

01/2004

NCT ID:

NCT00473538

Start Date:

January 2004

Completion Date:

August 2006

Related Keywords:

  • Polycystic Ovary Syndrome
  • Anovulation
  • Infertility
  • Structured exercise training program
  • Infertility
  • Menstrual cycle
  • PCOS
  • Treatment
  • Anovulation
  • Infertility
  • Polycystic Ovary Syndrome

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