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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


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

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Trial Information

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


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.


Inclusion Criteria:



- PCOS

- Anovulation

Exclusion Criteria:

- Major Medical Condition

- Severe Obesity

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Ovulation rate

Outcome Time Frame:

three months

Safety Issue:

No

Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Magna Graecia

Authority:

Italy: The Italian Medicines Agency

Study ID:

06/2009

NCT ID:

NCT01004068

Start Date:

February 2008

Completion Date:

October 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • Anovulation
  • Clomiphene
  • Diet
  • Exercise
  • Infertility
  • PCOS
  • Physical activity
  • Treatment
  • Anovulation
  • Polycystic Ovary Syndrome

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