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OpenTrials
Completed

NCT Number: NCT04989244

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

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of gynecology, Department of human reproduction

Ljubljana, 1000, Slovenia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Other identifiable causes of infertility

Treatment and study plan

Weight Loss Program

Behavioral

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

Primary outcomes

  1. Body weight (kg)

    Time frame: 8 weeks

    Body weight before and after the weight loss program will be measured.

  2. BMI (kg/m2)

    Time frame: 8 weeks

    BMI before and after the weight loss program will be calculated).

  3. Waist circumference (cm)

    Time frame: 8 weeks

    Waist circumference before and after the weight loss program will be measured.

  4. Abdominal circumference (cm)

    Time frame: 8 weeks

    Abdominal circumference

Secondary outcomes

  1. Spontaneous conception rate

    Time frame: 3 months

    Spontaneous pregnancy rate after weight loss program will be calculated.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • Slovenian Research Agency

Registry information

Official study title

Weight Loss Program in Infertile PCOS Women With Obesity

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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