Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program

March 12, 2024 updated by: Universitair Ziekenhuis Brussel

Optimising Preconceptual Health in Subfertile PCOS Patients. Implementation of a Lifestyle Modification Program Before Fertility Treatment, Impact on Health Related Quality of Life and Obstetric Outcome

Patients will be randomly assigned to a group where they undergo a 12-week lifestyle modification program prior to their fertility treatment, or a group where they are entitled to start their fertility treatment without prior lifestyle modification program.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

When allocated to the control arm patients will receive the standard of care combined with the foreseen questionnaires and bio-electric impedance analysis for body composition and ergospirometry. When the patient is allocated to the interventional arm she will receive a 12-week lifestyle modification program prior to her fertility treatment. The lifestyle modification program will consist of dietary advice, advice for physical activity and emotional support. After the 12-week program the fertilty treatment will start as per routine practice. Questionnaires, ergospirometry and bio-electric impedance analysis will also be performed at the foreseen moments.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subfertile patients between >18- <38 years old requesting fertility treatment at our centre
  • PCOS phenotypes A, B, C and D according to the NIH 2012 extension of the ESHRE/ASRM 2003 diagnostic criteria
  • BMI >27 and <38 (Jiskoot et al. 2017)
  • Nulliparous women
  • Patient gives consent voluntarily

Exclusion Criteria:

Patients will be excluded if they:

  • do not meet the ESHRE/ASRM 2003 diagnostic PCOS criteria
  • Have a BMI <27 and >38 (Jiskoot et al. 2017)
  • Need Surgical sperm retrieval
  • Use donor eggs
  • Need Pre-implantation genetic testing (PGT)
  • Multiparous women
  • cannot reliably fill out the questionnaires or comprehend the intervention, because of a language barrier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lifestyle intervention group
12-week lifestyle modification programme through face-to-face lifestyle counseling and physiotherapy combined with a follow-up programme using video consultations and online training sessions
Behavioral: Lifestyle program
If the patient is allocated to the interventional group, the lifestyle modification program will be planned/started immediately after the intake at the fertility clinic. The lifestyle modification program has a duration of 12 weeks in which the subject will receive follow-up by the endocrinologist/diabetologist and dietitian to re-ceive an active dietary intervention plan, follow-up by the physiotherapist where sessions to start with physical exercise will be given. Monthly follow-up visits with the coordinating PCOS-midwife will be planned to enhance the subject's knowledge about PCOS and give emotional support. At the moment of randomization, the PCOS coordinating midwife will immediately plan all necessary appointments, with the endocrinologist and dietitian, physiotherapist and PCOS-coordinator, for the 12-week lifestyle program. This way, patients will have a clear overview of the following 12 weeks.
No Intervention: Standard-of-care group
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight
Time Frame: 12 weeks after start of intervention
body weight (kg)
12 weeks after start of intervention
body composition
Time Frame: 12 weeks after start of intervention
body composition (Total Body Fat and Fat Free Mass), measured by using bio-electric im-pedance analysis (BIA)
12 weeks after start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Michel De Vos, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Actual)

February 26, 2024

Study Completion (Actual)

February 26, 2024

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSPCOLMMDV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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