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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Emmanuelle Mathieu d'Argent, MD
- 電話番号：+33 156 01 68 69
- メール：emmanuelle.mathieu@aphp.fr
研究連絡先のバックアップ
- 名前：Emile Darai, MD, PhD
- メール：emile.darai@tnn.aphp.fr
研究場所
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Ile De France
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Paris、Ile De France、フランス、75020
- 募集
- Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON
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コンタクト：
- Emmanuelle Mathieu d'Argent, MD
- 電話番号：+33 156 01 68 69
- メール：emmadargent@gmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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)
時間枠：5 years
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baseline data
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5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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rate of patients who will re-use their cryopreserved oocytes
時間枠：5 years
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follow up data
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5 years
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oocytes survival rate
時間枠：5 years
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follow up data
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5 years
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pregnancy rate
時間枠：5 years
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follow up data
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5 years
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birth rate
時間枠：5 years
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follow up data
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5 years
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live birth rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Emmanuelle Mathieu d'Argent, MD、Assistance Publique - Hôpitaux de Paris
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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