Infertile Polycystic Ovary Syndrome (PCOS) Women With Obesity and Lifestyle Changes

July 24, 2021 updated by: Tanja Burnik Papler, University Medical Centre Ljubljana

Weight Loss Program in Infertile PCOS Women With Obesity

Infertile PCOS women with obesity were included into lifestyle change weight loss program prior to inclusion to IVF procedures. They attended group as well as individual workouts and they were advised on healthy eating.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The weight loss program will consist of dietary change and exercise program which will be performed 3 times weekly.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Division of gynecology, Department of human reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI over 30 kg/m2
  • PCOS
  • Primary or secondary infertility
  • normal partner's semen

Exclusion Criteria:

  • Other identifiable causes of infertility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight (kg)
Time Frame: 8 weeks
Body weight before and after the weight loss program will be measured.
8 weeks
BMI (kg/m2)
Time Frame: 8 weeks
BMI before and after the weight loss program will be calculated).
8 weeks
Waist circumference (cm)
Time Frame: 8 weeks
Waist circumference before and after the weight loss program will be measured.
8 weeks
Abdominal circumference (cm)
Time Frame: 8 weeks
Abdominal circumference
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous conception rate
Time Frame: 3 months
Spontaneous pregnancy rate after weight loss program will be calculated.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

Slovenian Research Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 24, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 24, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBP1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Loss

Clinical Trials on Weight loss program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe