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

NCT05084274 | Terminated DMC

• 1 other identifier: LSPCOLMMDV
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; Polycystic Ovarian Syndrome; Lifestyle

Outcome Measures

Primary Outcomes (2)

• body weight

  body weight (kg)

  12 weeks after start of intervention

• body composition

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

  12 weeks after start of intervention

Study Arms (2)

Lifestyle intervention group

ACTIVE COMPARATOR

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

Standard-of-care group

NO INTERVENTION

No intervention

Interventions

Lifestyle program BEHAVIORAL

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.

Lifestyle intervention group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Michel De Vos

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: September 10, 2021
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)