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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT05084274
Collaborator
(none)
226
Enrollment
1
Location
2
Arms
37.7
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle program
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
226 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 10, 2021
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. body weight [12 weeks after start of intervention]

    body weight (kg)

  2. body composition [12 weeks after start of intervention]

    body composition (Total Body Fat and Fat Free Mass), measured by using bio-electric im-pedance analysis (BIA)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 38 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitair Ziekenhuis Brussel Brussel Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Michel De Vos, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT05084274
Other Study ID Numbers:
  • LSPCOLMMDV
First Posted:
Oct 19, 2021
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Infertility
Infertility, Female

Study Results

No Results Posted as of Oct 19, 2021