Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02741-38 | Other Identifier | IDRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Women aged 18-26 years with congenital (Turner syndrome or other determined or undetermined genetic cause) or acquired (post-therapeutic) |
| |
| Controls | Women aged 18-26 years who do not have a condition that compromises their fertility |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionary patients | Other | The patients will answer 1 questionnaire consisting of 5 parts :
|
| 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 |
| 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. |
Not provided
Inclusion 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
Exclusion Criteria:
Female
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise DURANTEAU, Doctor | Contact | 00331 45 21 78 41 | lise.duranteau@aphp.fr | |
| Iris GUILLAUME, Resident | Contact | irisguilhaume@hotmail.fr |
| Name | Affiliation | Role |
|---|---|---|
| Lise DURANTEAU, Doctor | Hospital Bicetre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Bicetre | Le Kremlin-BicĂȘtre | 94275 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionary controls | Other | Witnesses will complete 1 survey containing 4 parts:
|
|
Assess by the Hospital Anxiety and Depression questionnaire to help identify those with symptoms of anxiety or depression. |
| 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |