Parental Project and Premature Ovarian Insufficiency

Infertility Clinical Trial

— ParentIOP  

Official title:

Parental Project and Premature Ovarian Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310617
• Other study ID #: APHP220208
• Status: Completed
• Start date: June 20, 2022
• Est. completion date: June 20, 2022

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Menopause, Premature
• Primary Ovarian Insufficiency

Intervention

Other:
• Survey
Survey on the parental project and its realisation

Locations

Country	Name	City	State
France	Service d'endocrinologie et médecine de la reproduction	Paris

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	Realisation of parental project	Determine proportion of patient who realised a parental project after the diagnosis of POI	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Determine how and to what extent they have carried out their parental project	Evaluation if, after the diagnosis of POI, the parental project was realized through: spontaneous pregnancy or egg donation, simple stimulation or in vitro fertilization, embryo reception, or the adoption of a child after the diagnosis of POI	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	determine how many children on average these patients had after the diagnosis of POI.	Evaluation of the number of children born after the diagnosis of POI	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	determine the delay between the diagnosis of POI and the birth of the first child after the diagnosis according to the method	Evaluation of the time between the diagnosis of POI and the birth of the first child after diagnosis according to the method (egg donation, spontaneous pregnancy, adoption, etc.)	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o age at diagnosis	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o AMH level	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o FSH level	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o presence of follicles on ultrasound	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o cause of POI	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o number of pregnancies prior to diagnosis	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o number of children before diagnosis	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o normal puberty	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Secondary	Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o age at menarche	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed