自然周期における正倍体胚の凍結移植後の生殖結果に対する子宮内膜の圧縮の影響 (Compaction)
自然周期における正倍数体胚の凍結移植後の生殖成績に対する子宮内膜の圧縮の影響：前向きコホート研究
Multicenter prospective observational cohort study, comparing ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of the transfer versus those who have a stable or greater endometrial thickness with respect to the estrogenic phase.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Multicenter prospective observational cohort study. Based on our sample size calculation, the study group will consist of 206 women (exposed or "compaction" group: 103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase and the day of embryo transfer; non-exposed "non-compaction" group: 103 women with similar or greater endometrial thickness between these time points). The main objective of this study is to compare the ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of transfer versus those who with a stable or greater endometrial thickness with respect to the estrogenic phase. The estimated duration of the study is 24-30 months. Inclusion criteria are: 18 to 50 years of age, with primary or secondary infertility, subjected to endometrial preparation in a modified natural cycle for transfer of a genetically euploid blastocyst, from their own oocyte or oocyte donation, with a normal uterine cavity. Exclusion criteria are: uterine or endometrial disease (e.g., multiple myomatosis, severe adenomyosis, Asherman syndrome, refractory endometrium), conditions that prevent correct ultrasound assessment (tilted uterus), or a history of recurrent implantation failure or repeated miscarriages.
研究の種類
研究の種類
入学 (実際)
入学
連絡先と場所
研究場所
-
-
Madrid
-
Madrid、Madrid、スペイン、28001
- Instituto Bernabeu
-
-
参加基準
適格基準
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
206 Women between 18-50 years, with primary or secondary infertility, undergoing fertility treatment that includes endometrial preparation in a modified natural cycle for transfer of previously analyzed frozen and euploid embryos.
説明
Inclusion Criteria:
- Aged 18 to 50 years
- Primary or secondary infertility
- Normal uterine cavity
- Endometrial preparation in a modified natural cycle for single embryo transfer
- Embryo in blastocyst state from own oocyte or oocyte donation cycles, who had normal results on preimplantation genetic testing for aneuploidy (PGT-A) via trophectoderm biopsy.
Exclusion Criteria:
- Uterine or endometrial disease (multiple myomatosis [>3 fibroids of > 3 cm], adenomyosis, Asherman syndrome)
- Difficulties in correctly measuring endometrial thickness due to a retroverted or tilted uterus
- History of recurrent implantation failure (3 or more transferred blastocysts of good quality, from their own oocyte [<35 years] or oocyte donation); recurrent early Pregnancy Loss (the loss of two or more pregnancies before 10 weeks of gestational age.
- Suboptimal endometrial response (endometrium < 6 mm on the day of ovulation triggering).
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
exposed or "compaction" group
103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase (ovulation induction day) and the day of embryo transfer (7 days after ovulation induction). |
An additional control scan will be performed vaginally the day of the embryo transfer. Rest of follow up and treatment will be executed as usually. |
|
non-exposed "non-compaction" group
103 women with similar or greater endometrial thickness between the estrogenic phase (ovulation induction day) and the day of embryo transfer (7 days after ovulation induction). |
An additional control scan will be performed vaginally the day of the embryo transfer. Rest of follow up and treatment will be executed as usually. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ongoing pregnancy rate
時間枠：8-10 weeks gestational age.
|
Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age. |
8-10 weeks gestational age.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Biochemical pregnancy loss
時間枠：9-10 days after the embryo transfer.
|
Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation. |
9-10 days after the embryo transfer.
|
|
Clinical pregnancy
時間枠：5-6 weeks gestational age.
|
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. |
5-6 weeks gestational age.
|
|
Ectopic pregnancy
時間枠：5-8 weeks gestational age.
|
ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity. |
5-8 weeks gestational age.
|
|
Early pregnancy loss
時間枠：5-10 weeks gestational age.
|
spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week). |
5-10 weeks gestational age.
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- スタディディレクター：Juan Carlos J Castillo Farfan, Doctor、Instituto Bernabeu Alicante
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- Compaction Study
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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