Evaluation of Child Desire in Young Women With Premature Ovarian Failure (DESIOP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Ovarian Failure (POF)
• Intervention / Treatment: Other: Questionary patients; Other: Questionary controls

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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Lise DURANTEAU, Doctor; Phone Number: 00331 45 21 78 41; Email: lise.duranteau@aphp.fr
• Study Contact Backup: Name: Iris GUILLAUME, Resident; Email: irisguilhaume@hotmail.fr

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94275
    • Hospital BICETRE
    • Contact: Lise DURANTEAU, Doctor; Phone Number: 00331 45 21 78 41; Email: lise.duranteau@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Women aged 18-26 years with congenital (Turner syndrome or other determined or undetermined genetic cause) or acquired (post-therapeutic)	Other: 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
Controls; Women aged 18-26 years who do not have a condition that compromises their fertility	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the sexual life of women with POF	Assess the sexual life of women in POF by answering a questionary compared to the answers of controls. - The score of patients will be compared to the score of controls.	3 months
Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression.	Assess by the Hospital Anxiety and Depression questionnaire to help identify those with symptoms of anxiety or depression.	3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Lise DURANTEAU, Doctor, Hospital BICETRE

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2021
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): January 30, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Desire children, infertility, medical assisted procreation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: APHP210157; 2020-A02741-38 (Other Identifier: IDRCB)

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