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

Primary Purpose

Polycystic Ovary Syndrome

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cyproterone Acetate + estradiol
Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Polycystic Ovary Syndrome focused on measuring hypothalamus, Diffusion Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy

Eligibility Criteria

19 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Jeanne de Flandres, CHU

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

PCOS women

Healthy volunteers

Arm Description

26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.

26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Plasma GnRH concentration before and after treatment (PCOS patient and control group)
Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.

Full Information

First Posted
January 31, 2017
Last Updated
November 8, 2022
Sponsor
University Hospital, Lille
Collaborators
National Research Agency, France
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1. Study Identification

Unique Protocol Identification Number
NCT03043924
Brief Title
Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
National Research Agency, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
hypothalamus, Diffusion Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCOS women
Arm Type
Other
Arm Description
26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.
Intervention Type
Drug
Intervention Name(s)
Cyproterone Acetate + estradiol
Other Intervention Name(s)
Androcur, Provames
Intervention Description
PCOS will receive: 50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet
Other Intervention Name(s)
Leeloo Gé®
Intervention Description
Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)
Primary Outcome Measure Information:
Title
Change in the Apparent Diffusion Coefficient (ADC)
Description
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.
Time Frame
Baseline and 3 months after treatment start
Secondary Outcome Measure Information:
Title
Change in the metabolite concentrations
Description
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.
Time Frame
Baseline and 3 months after treatment start
Title
Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH)
Description
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.
Time Frame
Baseline and 3 months after treatment start
Title
Correlation coefficient (Spearman or Pearson) between the metabolite concentrations and serum hormonal levels (FSH, luteinizing hormone, oestradiol, AMH)
Description
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.
Time Frame
Baseline and 3 months after treatment start
Title
Plasma GnRH concentration before and after treatment (PCOS patient and control group)
Time Frame
Baseline and 3 months after treatment start
Title
Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.
Time Frame
Baseline and 3 months after treatment start

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Dewailly, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jeanne de Flandres, CHU
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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