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Completed

NCT Number: NCT03043924

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

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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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

19 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jeanne de Flandres, CHU

Lille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyproterone Acetate + estradiol

Drug

PCOS will receive:

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

Other names: Androcur, Provames

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®)

Other names: Leeloo Gé®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Plasma GnRH concentration before and after treatment (PCOS patient and control group)

    Time frame: Baseline and 3 months after treatment start

  5. Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.

    Time frame: Baseline and 3 months after treatment start

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • National Research Agency, France

Registry information

Official study title

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

Acronym: MRI-PCOS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2017
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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