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临床试验/NCT05310617
NCT05310617已完成不适用

Parental Project and Premature Ovarian Insufficiency

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
324
试验地点
1
主要终点
Realisation of parental project

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Realisation of parental project

时间窗: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed

Determine proportion of patient who realised a parental project after the diagnosis of POI

次要结局

  • Survey. Describe the characteristics of patients who were able to have a child after diagnosis(data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed)
  • Determine how and to what extent they have carried out their parental project(data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed)
  • determine how many children on average these patients had 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)
  • determine the delay between the diagnosis of POI and the birth of the first child after the diagnosis according to the method(data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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