Evaluation of Child Desire in Young Women With Premature Ovarian Failure

NCT ID: NCT04881695

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2022-01-30

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.

Detailed Description

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. The primary endpoint is the percentage of women with POF reporting a desire to have a child (yes / no) vs. controls of the same age with normal gonadal function/ The answers will be collected on two online questionnaires.

The secondary endpoints are:

• Look for a difference in the desire for a child according to the age at the diagnosis of POF, the cause of POF, the intake of hormone replacement therapy and the age of the patients at the time of the study.
• Assess the sexual life of women in POF.
• Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression. He will be assessed by the Hospital Anxiety and Depression Questionnaire to help identify those with symptoms of anxiety or depression.

The women will be contacted by email and will receive a newsletter. The controls will be recruited from patients who have visited at least once at bicetre Hospital and who do not have a condition that could impair fertility. They must not have been pregnant or must not be pregnant at the time of the study. The email will contain a questionnaire.

We estimate that 120 patients will meet the inclusion and non-inclusion criteria among the patients on the Unit.

Considering that 80 patients (2/3) will answer the questionnaires, we will be able to include 80 patients and 80 controls in our study.

The proportion of women wishing to have children, in the general population, in the study age group is estimated at 90%. Including 160 participants will allow us to show a 20% difference in the proportion of desire to have children in patients with POF, with a power of 90%, an alpha risk of 5% and a bilateral formulation.

Conditions

Premature Ovarian Failure (POF)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

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

Questionary patients

Intervention Type: 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

Controls

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

Questionary controls

Intervention Type: OTHER

Witnesses will complete 1 survey containing 4 parts:

• General (demographic information)
• Desire to have a child
• Hospital Anxiety and Depression scale
• Sexual life

Interventions

Questionary patients

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

Intervention Type: OTHER

Questionary controls

Witnesses will complete 1 survey containing 4 parts:

• General (demographic information)
• Desire to have a child
• Hospital Anxiety and Depression scale
• Sexual life

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lise DURANTEAU, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Bicetre

Locations

Hospital Bicetre

Le Kremlin-Bicêtre, , France

Countries

France

Central Contacts

Lise DURANTEAU, Doctor

Role: CONTACT

lise.duranteau@aphp.fr

00331 45 21 78 41

Iris GUILLAUME, Resident

Role: CONTACT

irisguilhaume@hotmail.fr

Facility Contacts

Lise DURANTEAU, Doctor

Role: primary

lise.duranteau@aphp.fr

00331 45 21 78 41

Other Identifiers

2020-A02741-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210157

Identifier Type: -

Identifier Source: org_study_id