Clinical trial · Interventional
Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Co-investigators have left and not been replaced.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility, Female | — | UNRESOLVED | — |
| Lifestyle | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lifestyle intervention group
- 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
- interventionNames
- Behavioral: Lifestyle program
- type
- NO_INTERVENTION
- label
- Standard-of-care group
- description
- No intervention
Primary outcomes (2)
- measure
- body weight
- timeFrame
- 12 weeks after start of intervention
- description
- body weight (kg)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available