Back to resultsInfertile Polycystic Ovary Syndrome (PCOS) Women With Obesity and Lifestyle Changes
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Weight loss program
Sponsored by
About this trial
This is an interventional other trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- BMI over 30 kg/m2
- PCOS
- Primary or secondary infertility
- normal partner's semen
Exclusion Criteria:
- Other identifiable causes of infertility
Sites / Locations
- Division of gynecology, Department of human reproduction
Outcomes
Primary Outcome Measures
Body weight (kg)
Body weight before and after the weight loss program will be measured.
BMI (kg/m2)
BMI before and after the weight loss program will be calculated).
Waist circumference (cm)
Waist circumference before and after the weight loss program will be measured.
Abdominal circumference (cm)
Abdominal circumference
Secondary Outcome Measures
Spontaneous conception rate
Spontaneous pregnancy rate after weight loss program will be calculated.
Full Information
NCT ID
NCT04989244
First Posted
July 1, 2021
Last Updated
July 24, 2021
Sponsor
University Medical Centre Ljubljana
Collaborators
Slovenian Research Agency
1. Study Identification
Unique Protocol Identification Number
NCT04989244
Brief Title
Infertile Polycystic Ovary Syndrome (PCOS) Women With Obesity and Lifestyle Changes
Official Title
Weight Loss Program in Infertile PCOS Women With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
Slovenian Research Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Weight loss program
Intervention Description
Women with obesity were included to the weight loss program which included physical exercise and dietary guidelines
Primary Outcome Measure Information:
Title
Body weight (kg)
Description
Body weight before and after the weight loss program will be measured.
Time Frame
8 weeks
Title
BMI (kg/m2)
Description
BMI before and after the weight loss program will be calculated).
Time Frame
8 weeks
Title
Waist circumference (cm)
Description
Waist circumference before and after the weight loss program will be measured.
Time Frame
8 weeks
Title
Abdominal circumference (cm)
Description
Abdominal circumference
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Spontaneous conception rate
Description
Spontaneous pregnancy rate after weight loss program will be calculated.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI over 30 kg/m2
PCOS
Primary or secondary infertility
normal partner's semen
Exclusion Criteria:
Other identifiable causes of infertility
Facility Information:
Facility Name
Division of gynecology, Department of human reproduction
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
35813634
Citation
Abdulkhalikova D, Sustarsic A, Vrtacnik Bokal E, Jancar N, Jensterle M, Burnik Papler T. The Lifestyle Modifications and Endometrial Proteome Changes of Women With Polycystic Ovary Syndrome and Obesity. Front Endocrinol (Lausanne). 2022 Jun 22;13:888460. doi: 10.3389/fendo.2022.888460. eCollection 2022.
Results Reference
derived
Learn more about this trial
Infertile Polycystic Ovary Syndrome (PCOS) Women With Obesity and Lifestyle Changes
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