Evaluation of Child Desire in Young Women With Premature Ovarian Failure

Premature Ovarian Failure (POF) Clinical Trial

— DESIOP  

Official title:

Evaluation of Child Desire in Young Women With Premature Ovarian Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04881695
• Other study ID #: APHP210157
• Secondary ID: 2020-A02741-38
• Status: Not yet recruiting
• Start date: May 10, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Lise DURANTEAU, Doctor
• Phone: 00331 45 21 78 41
• Email: lise.duranteau[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

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)

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure (POF)
• Primary Ovarian Insufficiency

Intervention

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
• 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

Locations

Country	Name	City	State
France	Hospital Bicetre	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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