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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00473538

Enrollment

Registered

2007-05-15

Start date

2004-01-31

Completion date

2006-08-31

Last updated

2007-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anovulation, Infertility, Polycystic Ovary Syndrome

Keywords

Structured exercise training program, Infertility, Menstrual cycle, PCOS, Treatment

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.

Interventions

BEHAVIORALStructured exercise training

BEHAVIORALHypocaloric hyperproteic diet

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pregnancy rate	six months

Secondary

Measure	Time frame
Menstrual frequency	six months
Abortion rate	six months
Compliance	six months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026