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

Not Applicable

Terminated

• Conditions: Lifestyle; Infertility, Female; Polycystic Ovarian Syndrome
• Interventions: Behavioral: Lifestyle program

• Registration Number: NCT05084274
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

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 Timeline

• Study Start: 2021-09-10
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Status Verified: 2024-02
• Primary Completion: 2024-02-26
• Study Completion: 2024-02-26
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention group	Lifestyle program	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

Primary Outcome Measures

Name	Time	Method
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)
body weight	12 weeks after start of intervention	body weight (kg)

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussel, Belgium