Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)
MRI-PCOS
2 other identifiers
interventional
52
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 6, 2017
CompletedStudy Start
First participant enrolled
September 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedDecember 11, 2025
December 1, 2025
4.6 years
January 31, 2017
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Apparent Diffusion Coefficient (ADC)
The change in the ADC will be analyzed in healthy volunteers and PCOS women before starting the oral contraceptives, and next during the third sequence of treatment.
Baseline and 3 months after treatment start
Secondary Outcomes (5)
Change in the metabolite concentrations
Baseline and 3 months after treatment start
Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH)
Baseline and 3 months after treatment start
Correlation coefficient (Spearman or Pearson) between the metabolite concentrations and serum hormonal levels (FSH, luteinizing hormone, oestradiol, AMH)
Baseline and 3 months after treatment start
Plasma GnRH concentration before and after treatment (PCOS patient and control group)
Baseline and 3 months after treatment start
Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.
Baseline and 3 months after treatment start
Study Arms (2)
PCOS women
OTHER26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.
Healthy volunteers
OTHER26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.
Interventions
Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)
PCOS will receive: 50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily
Eligibility Criteria
You may qualify if:
- For all subjects
- Aged from 19 to 30 years
- Body mass index : 18-25
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- National Research Agency, Francecollaborator
Study Sites (1)
Hôpital Jeanne de Flandres, CHU
Lille, France
Related Publications (1)
Barbotin 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: 37001236RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Didier Dewailly, MD,PhD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 6, 2017
Study Start
September 26, 2017
Primary Completion
April 15, 2022
Study Completion
April 15, 2022
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share