Sexuality and Sexual Quality of Life in Adult Patients With Turner Syndrome (TS) Compared With Patients With Primary Ovarian Insufficiency Different From TS

NCT05223621 | Unknown

• 2 other identifiers: APHP200833IDRCB 2020-A01768-31
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Turner syndrome (TS) is a rare disease affecting 1/2500 female. It is defined by a complete or partial loss of an X chromosome associated with clinical signs. The most frequent signs are a small height and primary ovarian insufficiency (POI). POI occurs in 95% of patients with TS. Clinically, patients have amenorrhea with elevated FSH levels (\> 25 IU/L), before the age of 40. In most cases, patients receive hormonal replacement therapy. Among patients with POI, TS is present in less than 10% of cases. Therefore POI may occur in patients with normal karyotype, therefore without TS. Preliminary data suggest altered sexual function in patients with TS. The first goal of our study is to evaluate sexual function and sexual quality in patients with TS using a questionnaire, the Female Sexual Function Index (FSFI). The second goal is to compare sexual quality in patients in patients with TS compared to female patients with POI not related to TS. Our study should identify predictive markers of altered sexual function. The final endpoint is to optimize the quality of life of patients with TS and to enhance, if necessary psychological support in such patients.

Conditions

Turner Syndrome; Primary Ovarian Insufficiency

Keywords

Sexual life; sexuality; Turner syndrome; primary ovarian insufficiency

Outcome Measures

Primary Outcomes (1)

• Sexuality anomalies with score (patient TS)

  Measuring sexuality anomalies thanks to FSFI-6 questionnaire by TS patients the day of inclusion (score between " 30 " corresponding to " no sexual abnormalities " and " 0 " corresponding to " maximum sexual abnormalities signs ".

  Day 1

Other Outcomes (2)

• Sexuality anomalies with score (patient POI)

  Day 1

• Evaluate predictive factors of sexual quality of life

  Day 1

Study Arms (2)

Turner

patients with Turner syndrome

POI

patients with primary ovarian failure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed in our reference center of rare diseases named CMERCD belonging to FIRENDO network of rare diseases in France ; our center is labelled as an endo-ERN center of rare diseases.

You may qualify if:

• karyotype with at least10% of 45,X cells
• age between 18-50
• followed in our reference centre

You may not qualify if:

• refusal of patients to participate
• Without health insurance
• Patients under supervision \& guardianship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital St Antoine, Sorbonne University, Endocrinology-Diabetology Department, Reproductive medicine

Paris, 75012, France

Location

MeSH Terms

Conditions

Turner Syndrome; Primary Ovarian Insufficiency; Sexuality

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases; Sexual Behavior; Behavior

Study Officials

• Sophie Christin-Maitre, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: February 4, 2022
• Study Start: February 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

FR (1)