Fertility Preservation in Case of Endometriosis (PREFENDO)
Fertility Preservation in Case of Endometriosis : Observational Cohort Study
Fertility Preservation is now considered as crucial for the well-being of women battling cancer. However, others indications have more recently emerged. Women with endometriosis may represent a suitable group since they are at risk for compromise ovarian reserve. Data on FP in endometriosis patients are rare: only small retrospective study, case-reports and opinion publications .Nowadays, there is no available data concerning real indications for PF on endometriosis patients (endometriomas, risk of surgery, deep endometriosis?), criteria for eligibility (ovarian reserve parameters, age), quality of oocytes and number of oocytes necessary to give at least one live birth.
We propose a monocentric observational cohort study, evaluating the efficacy of oocytes cryopreservation as fertility preservation procedure, in young adult female subjects with endometriosis, to finally define the criteria of eligibility for PF procedures in case of endometriosis.
연구 개요
상태
정황
상세 설명
Monocentric observational cohort study, enrolling young patients with endometriosis, without birth project for the moment, and asking for fertility preservation, in order to preserve mature oocytes.
Protocol of this study :
- information and signatures of consent file ;
- ovarian stimulation, oocytes retrieval and mature oocytes cryopreservation (one or more procedures)
- questionnaires every year, describing quality of life in this context of endometriosis and evolution (treatment, surgery, ART, pregnancies)
- data about number and rate of thawed oocytes after preservation, pregnancy rate and live birth rate with these oocytes.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Emmanuelle Mathieu d'Argent, MD
- 전화번호: +33 156 01 68 69
- 이메일: emmanuelle.mathieu@aphp.fr
연구 연락처 백업
- 이름: Emile Darai, MD, PhD
- 이메일: emile.darai@tnn.aphp.fr
연구 장소
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Ile De France
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Paris, Ile De France, 프랑스, 75020
- 모병
- Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON
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연락하다:
- Emmanuelle Mathieu d'Argent, MD
- 전화번호: +33 156 01 68 69
- 이메일: emmadargent@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- women from 18 to 36 years old
- endometriosis disease proved by sonography, MRI and/or surgery
- Consenting to participate to the study
Exclusion Criteria:
- Any contraindication for ovarian stimulation.
- Any contraindication for pregnancy .- Impossible Follow-up.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Women with endometriosis
Women with endometriosis disease aged 18-36 years, with appropriate endometriosis diagnosis, based on transvaginal sonography, magnetic resonance imaging and/or previous surgery.Ovarian reserve was assessed by antral follicle counting (AFC) and measurement of serum anti-Mullerian hormone (AMH) levels Enrolled after preservation fertility procedure (vitrification of mature oocytes)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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characteristics of patients who will benefit from preservation fertility in case of endometriosis (age, parameters of ovarian reserve, endometriosis stage and lesions, previous treatment or surgeries, previous fertility treatment)
기간: 5 years
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baseline data
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5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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rate of patients who will re-use their cryopreserved oocytes
기간: 5 years
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follow up data
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5 years
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oocytes survival rate
기간: 5 years
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follow up data
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5 years
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pregnancy rate
기간: 5 years
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follow up data
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5 years
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birth rate
기간: 5 years
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follow up data
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5 years
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live birth rate
기간: 5 years
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follow up data
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5 years
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Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire
기간: 5 years
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Patients complete a SF-36 questionnaire
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5 years
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Events between fertility preservation and re-use or end of the study 1
기간: 5 years
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Nature of surgical procedures for endometriosis during the year
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5 years
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Events between fertility preservation and re-use or end of the study 2
기간: 5 years
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Number of surgical procedures for endometriosis during the year
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5 years
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Events between fertility preservation and re-use or end of the study 3
기간: 5 years
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Pregnancy during the year (and type of pregnancy: abortion, clinical pregnancy, delivery)
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5 years
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Events between fertility preservation and re-use or end of the study 4
기간: 5 years
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Duration of medical treatement for endometriosis during the year: number of months during the year
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5 years
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Events between fertility preservation and re-use or end of the study 5
기간: 5 years
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Type of medical treatement for endometriosis during the year: class of molecule
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Emmanuelle Mathieu d'Argent, MD, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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