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

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05084274
• Other study ID #: LSPCOLMMDV
• Status: Terminated
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: February 26, 2024

Study information

• Verified date: February 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Lifestyle
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome

Intervention

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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	body weight (kg)	12 weeks after start of intervention
Primary	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