An interventional study of Lifestyle program in Infertility, Female, Polycystic Ovarian Syndrome and Lifestyle, sponsored by Universitair Ziekenhuis Brussel. Terminated at 1 site in Belgium. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment
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.
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
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Exclusion Criteria:
Patients will be excluded if they:
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
No intervention
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.
body weight
body weight (kg)
Time frame: 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)
Time frame: 12 weeks after start of intervention
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Universitair Ziekenhuis Brussel