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

NCT05084274 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-03-15

No results posted yet for this study

Summary

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.

Conditions

  • Infertility, Female
  • Polycystic Ovarian Syndrome
  • Lifestyle

Interventions

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.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Michel De Vos · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2024-02-26
Completion
2024-02-26

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05084274 on ClinicalTrials.gov