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

November 8, 2022 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Jeanne de Flandres, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PCOS women
26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.
Drug: Cyproterone Acetate + estradiol

PCOS will receive:

50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily

Other Names:
  • Androcur, Provames
Other: Healthy volunteers
26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.
Drug: 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®)
Other Names:
  • Leeloo Gé®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Apparent Diffusion Coefficient (ADC)
Time Frame: Baseline and 3 months after treatment start
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the metabolite concentrations
Time Frame: Baseline and 3 months after treatment start
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)
Time Frame: Baseline and 3 months after treatment start
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)
Time Frame: Baseline and 3 months after treatment start
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)
Time Frame: Baseline and 3 months after treatment start
Baseline and 3 months after treatment start
Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.
Time Frame: Baseline and 3 months after treatment start
Baseline and 3 months after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

National Research Agency, France

Investigators

  • Principal Investigator: Didier Dewailly, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2017

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_22
  • 2016-A01391-50 (Other Identifier: ID-RCB Number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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