Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program
NCT ID: NCT05084274
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2021-09-10
2024-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
Standard-of-care group
No intervention
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
38 Years
FEMALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Michel De Vos
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
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Universitair Ziekenhuis Brussel
Brussels, , Belgium
Countries
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Other Identifiers
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LSPCOLMMDV
Identifier Type: -
Identifier Source: org_study_id
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