Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

— MRI-PCOS  

Official title:

Functional Study of the Hypothalamus in High-resolution Magnetic Resonance Imaging (MRI) in Women With Polycystic Ovary Syndrome (PCOS): a Comparative Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03043924
• Other study ID #: 2016_22
• Secondary ID: 2016-A01391-50
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Cyproterone Acetate + estradiol
PCOS will receive: 50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily
• Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet
Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandres, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH)	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
Secondary	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
Secondary	Plasma GnRH concentration before and after treatment (PCOS patient and control group)		Baseline and 3 months after treatment start
Secondary	Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.		Baseline and 3 months after treatment start