Skip to main content
OpenTrials
Completed

NCT Number: NCT01004068

Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)

Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC. Structured exercise training (SET) and diet has been successfully employed to restore ovarian function and to improve reproductive outcomes in obese and overweight women with PCOS. The current study was aimed to test the hypothesis that a short-term SET program plus diet intervention can improve the ovarian response to CC in CC-resistant PCOS patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Anovulation Behavior Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Motor Activity Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

"Pugliese" Hospital

Catanzaro, 88100, Italy

About this study

Ninety-six PCOS patients considered CC-resistant because not responsive to 150 mg daily of CC were randomized in three arms (group A, B, and C). Group A underwent SET program plus hypocaloric diet for two months, group B had one month of observation followed by one-cycle of CC therapy, and group C underwent SET program plus hypocaloric diet for two months and received one-cycle of CC for one cycle. CC was always given at the maximal dose previously used. Clinical, hormonal and metabolic data were assessed at baseline and after intervention. Ovulation was monitored by ultrasound and confirmed by plasma progesterone assay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PCOS
  • Anovulation

Exclusion criteria

  • Major Medical Condition
  • Severe Obesity

Treatment and study plan

SET-diet plus clomiphene

Other

Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate

Other names: Lifestyle modification, CC

Clomiphene Citrate

Drug

Clomiphene citrate at 150 mg daily for one cycle

Other names: CC

Structured exercise program plus hypocaloric diet

Behavioral

SET plus diet

Other names: Lifestyle modifications

Primary outcomes

  1. Ovulation rate

    Time frame: three months

Secondary outcomes

  1. Clinical data

    Time frame: three months

  2. Metabolic data

    Time frame: three months

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

Does Short-term Structured Exercise Training Program Plus Diet Intervention Improve Ovarian Sensitivity to Clomiphene Citrate in Polycystic Ovary Syndrome Patients (PCOS)? A Prospective Randomized Controlled Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 29, 2009
Registry last updated
Nov 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.