Evaluation of Child Desire in Young Women With Premature Ovarian Failure

NCT04881695 | Unknown

• 2 other identifiers: APHP2101572020-A02741-38
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired. Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption. The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder.

Conditions

Premature Ovarian Failure (POF)

Keywords

Desire children, infertility, medical assisted procreation

Outcome Measures

Primary Outcomes (1)

• Percentage of POI patients expressing a desire for a child (yes/no) compared to controls of the same age with no fertility compromising condition,

  To compare the desire for children of patients with premature ovarian failure (POI) aged 18-26 years with controls of the same age group (inclusion stratified by age in 2-year strata) with no fertility compromising condition.

  3 months

Secondary Outcomes (2)

• Assess the sexual life of women with POF

  3 months

• Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression.

  3 months

Study Arms (2)

Patients

Women aged 18-26 years with congenital (Turner syndrome or other determined or undetermined genetic cause) or acquired (post-therapeutic)

Other: Questionary patients

Controls

Women aged 18-26 years who do not have a condition that compromises their fertility

Other: Questionary controls

Interventions

Questionary patients OTHER

The patients will answer 1 questionnaire consisting of 5 parts : * General (demographic information) * Desire for a child * Hospital Anxiety and Depression scale * Sexual life * Additional questions regarding medical care

Patients

Questionary controls OTHER

Witnesses will complete 1 survey containing 4 parts: * General (demographic information) * Desire to have a child * Hospital Anxiety and Depression scale * Sexual life

Controls

Eligibility Criteria

• Age: 18 Years - 26 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 to 26 with congenital POF (linked to Turner Syndrome or to another determined or undetermined genetic cause) or acquired (post-treatment), having consulted at least once at the bicetre hospital.

You may qualify if:

• Women aged 18 to 26
• Diagnosed with POF according to the following criteria:
• Absence of pubertal development or primary or secondary amenorrhea for more than 4 months Follicle Stimulating Hormone (FSH) rate\> 40 mL U /L, on at least two separate samples taken at least one month apart Low estradiol level \<40 pg / mL
• POF of congenital (Turner syndrome or other genetic cause) or acquired (post-therapeutic) origin
• Who consulted in the Adolescent and Young Adult Gynecology Unit at bicetre Hospital between 2014 and 2021

You may not qualify if:

• Minor patient or over 26 years old
• Inability to complete the questionnaire
• Lack of social security coverage
• Patient under state medical aid
• Patient under guardianship or curators or under legal protection
• POF not confirmed (for patients only)
• Condition impacting fertility or having already been pregnant or pregnant at the time of the study (for controls)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Infertility

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Lise DURANTEAU, Doctor

  Hospital Bicetre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise DURANTEAU, Doctor

CONTACT

00331 45 21 78 41; lise.duranteau@aphp.fr

Iris GUILLAUME, Resident

CONTACT

irisguilhaume@hotmail.fr

Study Design

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

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 11, 2021
• Study Start: May 10, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)