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

NCT ID: NCT04989244

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-06-15

Brief Summary

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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

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

Conditions

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Weight Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Weight loss program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Other identifiable causes of infertility
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Slovenian Research Agency

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Tanja Burnik Papler

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of gynecology, Department of human reproduction

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type DERIVED
PMID: 35813634 (View on PubMed)

Other Identifiers

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TBP1

Identifier Type: -

Identifier Source: org_study_id

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