NCT01004068

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
Last Updated

November 3, 2010

Status Verified

November 1, 2009

Enrollment Period

1.7 years

First QC Date

July 15, 2009

Last Update Submit

November 2, 2010

Conditions

Polycystic Ovary SyndromeAnovulation

Keywords

ClomipheneDietExerciseInfertilityPCOSPhysical activityTreatment

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

    three months

Secondary Outcomes (2)

  • Clinical data

    three months

  • Metabolic data

    three months

Study Arms (3)

SET-diet plus clomiphene

EXPERIMENTAL

Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle

Other: SET-diet plus clomiphene

Clomiphene citrate

ACTIVE COMPARATOR

One month of observation followed by one-cycle of clomiphene citrate therapy

Drug: Clomiphene citrate

SET plus diet

EXPERIMENTAL

Lifestyle modifications for two months.

Behavioral: Structured exercise program plus hypocaloric diet

Interventions

SET-diet plus clomipheneOTHER

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

Also known as: Lifestyle modification, CC
SET-diet plus clomiphene
Clomiphene citrateDRUG

Clomiphene citrate at 150 mg daily for one cycle

Also known as: CC
Clomiphene citrate
Structured exercise program plus hypocaloric dietBEHAVIORAL

SET plus diet

Also known as: Lifestyle modifications
SET plus diet

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS
  • Anovulation

You may not qualify if:

  • Major Medical Condition
  • Severe Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Pugliese" Hospital

Catanzaro, 88100, Italy

Location

Related Publications (3)

  • Vigorito C, Giallauria F, Palomba S, Cascella T, Manguso F, Lucci R, De Lorenzo A, Tafuri D, Lombardi G, Colao A, Orio F. Beneficial effects of a three-month structured exercise training program on cardiopulmonary functional capacity in young women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Apr;92(4):1379-84. doi: 10.1210/jc.2006-2794. Epub 2007 Jan 30.

    PMID: 17264174BACKGROUND

  • Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.

    PMID: 18158291BACKGROUND

  • Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.

    PMID: 20858697RESULT

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulationMotor ActivityInfertility

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Stefano Palomba, MD

    University Magna Graecia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2009

First Posted

October 29, 2009

Study Start

February 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 3, 2010

Record last verified: 2009-11

Locations

IT(1)