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NCT04989244 Clinical Trial

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

Weight Loss Clinical Trial

Official title:
Weight Loss Program in Infertile PCOS Women With Obesity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04989244
Other study ID # TBP1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date June 15, 2020

Study information
Verified date July 2021
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date June 15, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria: - BMI over 30 kg/m2 - PCOS - Primary or secondary infertility - normal partner's semen Exclusion Criteria: - Other identifiable causes of infertility

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Weight loss program
Women with obesity were included to the weight loss program which included physical exercise and dietary guidelines

Locations
Country Name City State
Slovenia Division of gynecology, Department of human reproduction Ljubljana

Sponsors (2)
Lead Sponsor Collaborator
University Medical Centre Ljubljana Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body weight (kg) Body weight before and after the weight loss program will be measured. 8 weeks
Primary BMI (kg/m2) BMI before and after the weight loss program will be calculated). 8 weeks
Primary Waist circumference (cm) Waist circumference before and after the weight loss program will be measured. 8 weeks
Primary Abdominal circumference (cm) Abdominal circumference 8 weeks
Secondary Spontaneous conception rate Spontaneous pregnancy rate after weight loss program will be calculated. 3 months
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