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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01391-50 | Other Identifier | ID-RCB Number, ANSM |
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| Name | Class |
|---|---|
| National Research Agency, France | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCOS women | Other | 26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited. |
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| Healthy volunteers | Other | 26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyproterone Acetate + estradiol | Drug | PCOS will receive: 50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the metabolite concentrations | The change in the metabolite concentrations will be analyzed in the two groups before starting the oral contraceptives, and next during the third sequence of treatment. | Baseline and 3 months after treatment start |
| Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH) |
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Inclusion Criteria:
For all subjects
For Healthy volunteers subjects :
PCOS women:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Dewailly, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jeanne de Flandres, CHU | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37001236 | Result | 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. |
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| Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet | Drug | Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®) |
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The correlation between ADC and hormonal levels in the two groups will be analysed before starting the contraceptive treatment and during the third processing sequence. |
| 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) | The correlation between metabolite concentrations and hormonal levels in the two groups will be analysed before starting the contraceptive treatment and during the third processing sequence. | 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 |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017373 | Cyproterone Acetate |
| D004958 | Estradiol |
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D003534 | Cyproterone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004963 | Estrenes |
| D004962 | Estranes |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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