Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-14 @ 1:26 PM
Study NCT ID:
NCT04881695
Status:
UNKNOWN
Last Update Posted:
2021-05-11
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Child Desire in Young Women With Premature Ovarian Failure
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Evaluation of Child Desire in Young Women With Premature Ovarian Failure
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DESIOP
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A02741-38 | OTHER | IDRCB | View |