NCT00473538

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Typical duration for phase_4

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

January 1, 2004

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

May 14, 2007

Last Update Submit

November 13, 2007

Conditions

Polycystic Ovary SyndromeAnovulationInfertility

Keywords

Structured exercise training programInfertilityMenstrual cyclePCOSTreatment

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    six months

Secondary Outcomes (3)

  • Menstrual frequency

    six months

  • Abortion rate

    six months

  • Compliance

    six months

Interventions

Structured exercise trainingBEHAVIORAL
Hypocaloric hyperproteic dietBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • PCOS
  • Anovulatory infertility
  • Obesity (BMI \>30)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Pugliese" Hospital

Catanzaro, 88100, Italy

Location

Related Publications (4)

  • 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

  • Clark AM, Ledger W, Galletly C, Tomlinson L, Blaney F, Wang X, Norman RJ. Weight loss results in significant improvement in pregnancy and ovulation rates in anovulatory obese women. Hum Reprod. 1995 Oct;10(10):2705-12. doi: 10.1093/oxfordjournals.humrep.a135772.

    PMID: 8567797BACKGROUND

  • Norman RJ, Noakes M, Wu R, Davies MJ, Moran L, Wang JX. Improving reproductive performance in overweight/obese women with effective weight management. Hum Reprod Update. 2004 May-Jun;10(3):267-80. doi: 10.1093/humupd/dmh018.

    PMID: 15140873BACKGROUND

  • 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: 18158291DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulationInfertility

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stefano Palomba, MD

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

    PRINCIPAL INVESTIGATOR

  • Francesco Orio, MD

    Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II" of Naples, and Chair of Endocrinology, University "Parthenope", of Naples

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 15, 2007

Study Start

January 1, 2004

Study Completion

August 1, 2006

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

IT(1)