Clinical trial · Interventional
Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)
Functional Study of the Hypothalamus in High-resolution Magnetic Resonance Imaging (MRI) in Women With Polycystic Ovary Syndrome (PCOS): a Comparative Study
NCT03043924CI-TRIAL-00098827MRI-PCOScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is associated with transient microstructural and metabolic changes in the female hypothalamus using MRI approaches to assess water diffusion and measure proton magnetic resonance spectra.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyproterone Acetate + estradiol | Drug | — | UNRESOLVED |
| Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- PCOS women
- description
- 26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.
- interventionNames
- Drug: Cyproterone Acetate + estradiol
- type
- OTHER
- label
- Healthy volunteers
- description
- 26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.
- interventionNames
- Drug: Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet
Primary outcomes (1)
- measure
- Change in the Apparent Diffusion Coefficient (ADC)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: For all subjects * Aged from 19 to 30 years * Body mass index : 18-25 * Informed consent before inclusion * Do not smoke the 3 days before the MRI For Healthy volunteers subjects : * Regular cycles (between 25 and 35 days) AND ovulatory. * No signs of hyperandrogenism. * Subjects desirous of taking oral contraceptives (estrogen/progestin combination). * For the realization of the 2nd MRI: to be during the 3rd month of a treatment well followed by oestro-progestative monophasic minidose to 0,02mg of Ethinyl-oestradiol / 0,1mg Levonorgestrel. PCOS women: * PCOS defined by Rotterdam criteria * Needing a treatment with cyproterone acetate * To carry out the 2nd MRI: to be in progress during the 3rd month of a treatment well followed by 50 mg of Cyproterone acetate in association with 2mg / day of natural estradiol. Exclusion Criteria: * Hormone treatment within 3 months prior to inclusion (including birth control pill ) * On-going pregnancy (determined before each MRI scan visit) * Claustrophobia * Any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators) * Diabetes or known dysthyroidism. * Current substance abuse (including smoking more than 5 cigarettes/day; determined using drug screening at the screening visit) * Pregnancy or breastfeeding the last 3 months. * Practice of intense physical exercise (ex jogging\> 10km) the day before the MRI. * Person incapable of consenting, or enjoying legal protection (guardianship / curatorship). * Unability to understand the treatment protocol
References
Publications (1)
- RESULTBarbotin AL, Mimouni NEH, Kuchcinski G, Lopes R, Viard R, Rasika S, Mazur D, Silva MSB, Simon V, Boursier A, Pruvo JP, Yu Q, Candlish M, Boehm U, Bello FD, Medana C, Pigny P, Dewailly D, Prevot V, Catteau-Jonard S, Giacobini P. Hypothalamic neuroglial plasticity is regulated by anti-Mullerian hormone and disrupted in polycystic ovary syndrome. EBioMedicine. 2023 Apr;90:104535. doi: 10.1016/j.ebiom.2023.104535. Epub 2023 Mar 29. PMID 37001236