Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program
Primary Purpose
Infertility, Female, Polycystic Ovarian Syndrome, Lifestyle
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Lifestyle program
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility Criteria
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
Sites / Locations
- Universitair Ziekenhuis BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lifestyle intervention group
Standard-of-care group
Arm Description
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
No intervention
Outcomes
Primary Outcome Measures
body weight
body weight (kg)
body composition
body composition (Total Body Fat and Fat Free Mass), measured by using bio-electric im-pedance analysis (BIA)
Secondary Outcome Measures
Full Information
NCT ID
NCT05084274
First Posted
October 6, 2021
Last Updated
April 14, 2023
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05084274
Brief Title
Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Polycystic Ovarian Syndrome, Lifestyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle intervention group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard-of-care group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle program
Intervention Description
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.
Primary Outcome Measure Information:
Title
body weight
Description
body weight (kg)
Time Frame
12 weeks after start of intervention
Title
body composition
Description
body composition (Total Body Fat and Fat Free Mass), measured by using bio-electric im-pedance analysis (BIA)
Time Frame
12 weeks after start of intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel De Vos, PhD
Phone
+3224776648
Email
mdevos@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Linde De Vos
Phone
+3224776648
Email
linde.mostinckx@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel De Vos
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linde Mostinckx
Email
Linde.Mostinckx@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Elsie Nulens
Email
Elsie.nulens@uzbrussel.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program
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