Clinical trial NCT05310617: Parental Project and Premature Ovarian Insufficiency
Official title: Parental Project and Premature Ovarian Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Ovarian Insufficiency
Infertility
Keywords: spontaneous pregnancy
adoption
oocyte donation
parental project
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with POI who were hospitalized in a day hospital (HDJ) in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière hospital for the etiological assessment of ovarian insufficiency and its repercussions between 31/12/1982 and 12/01/2021

Brief summary: One of the main repercussions of POI is infertility. When the diagnosis of POI is announced, the question of fertility is addressed and the patient is often directed towards egg donation or adoption when she has a parental project. However, there are cases of spontaneous pregnancies after diagnosis.

This study was conducted to determine the proportion of patients with POI who were able to realize a parental project after diagnosis in the long term and by what means.

Detailed description: The investigators propose to study patients with POI who were hospitalized in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière Hospital for the etiological assessment of ovarian failure and its consequences between December 31, 1982 and January 12, 2021. The investigators will only include patients who were admitted to the day hospital because we have a complete etiological workup and a complete history for them, which allows investigators to describe the population properly. The patients must be over 18 years old at the time of the survey in order to be able to evaluate the presence of a parental project only in adult patients.

Patients for whom there is no valid contact information in the computer file (postal address or valid email address or cell phone number) or whose last consultation was more than 2 years ago will be excluded. Patients with Turner syndrome will be excluded because they may have comorbidities, particularly cardiac, that contraindicate pregnancy. Patients with POI secondary to oncological treatments (gonadotoxic chemotherapy or pelvic radiotherapy) will also be excluded because of the uncertain prognosis and the contraindications to pregnancy in case of hormone-dependent tumors.

Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years old at the time of the survey
* Patients with a diagnosis of PIO according to the current definition: cycle disturbances of more than 4 months and FSH \> 25 on 2 measurements one month apart
* Patients having been hospitalized in day hospital (HDJ) in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière hospital for the etiological assessment of ovarian insufficiency and its repercussions between December 31, 1982 and January 12, 2021
* Valid contact information available: address, cell phone, e-mail
* Patients who have been informed and do not object to participate in the study

Exclusion Criteria:

* Turner syndrome
* POI secondary to oncology treatments (chemotherapy, pelvic radiotherapy)
* Opposition to participating in the study

Primary outcomes:
measure: Realisation of parental project
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary outcomes:
measure: Determine how and to what extent they have carried out their parental project
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: determine how many children on average these patients had after the diagnosis of POI.
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: determine the delay between the diagnosis of POI and the birth of the first child after the diagnosis according to the method
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
measure: Survey. Describe the characteristics of patients who were able to have a child after diagnosis
timeFrame: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'endocrinologie et médecine de la reproduction
Study officials:
affiliation: APHP
name: Philippe Touraine, Pr
role: PRINCIPAL_INVESTIGATOR
References: