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

Not Applicable

Completed

• Conditions: Weight Loss

• Registration Number: NCT04989244
• Lead Sponsor: University Medical Centre Ljubljana

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-06-15
• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-24
• Last Update Submitted: 2021-07-24
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Waist circumference (cm)	8 weeks	Waist circumference before and after the weight loss program will be measured.
Abdominal circumference (cm)	8 weeks	Abdominal circumference
Body weight (kg)	8 weeks	Body weight before and after the weight loss program will be measured.
BMI (kg/m2)	8 weeks	BMI before and after the weight loss program will be calculated).

Secondary Outcome Measures

Name	Time	Method
Spontaneous conception rate	3 months	Spontaneous pregnancy rate after weight loss program will be calculated.

Trial Locations

Locations (1)

Division of gynecology, Department of human reproduction; 🇸🇮 Ljubljana, Slovenia