NCT04989244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

July 1, 2021

Last Update Submit

July 24, 2021

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (4)

  • Body weight (kg)

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

    8 weeks

  • BMI (kg/m2)

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

    8 weeks

  • Waist circumference (cm)

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

    8 weeks

  • Abdominal circumference (cm)

    Abdominal circumference

    8 weeks

Secondary Outcomes (1)

  • Spontaneous conception rate

    3 months

Interventions

Weight loss programBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Other identifiable causes of infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of gynecology, Department of human reproduction

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 35813634DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

July 1, 2021

First Posted

August 4, 2021

Study Start

September 1, 2019

Primary Completion

May 1, 2020

Study Completion

June 15, 2020

Last Updated

August 4, 2021

Record last verified: 2021-07

Locations

SL(1)