Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders (DT-HCG-IVF)
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders a Randomized Controlled Trial
To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles.
調査の概要
状態
詳細な説明
To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles.
- Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG.
- hCG Trigger Group: Participants will receive hCG alone.
primary Outcomes
The following primary outcomes will be assessed:
• Number of mature (MII) oocytes (assessment at denudation). Secondary Outcomes
The following secondary outcomes will be assessed:
- Number of retrieved oocytes.
- Fertilization rate.
- Number and quality of embryos.
- Implantation rate.
- Clinical pregnancy rate.
- Multiple pregnancy rate.
- Incidence of ovarian hyperstimulation syndrome (OHSS).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ahmed MM Gebreel, MSc
- 電話番号：+201092576506
- メール：agebreel@hotmail.com
研究場所
-
-
Cairo Governorate
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Cairo、Cairo Governorate、エジプト
- 募集
- ART Unit, International Islamic Center for Population Studies and Research, Al-Azhar University
-
コンタクト：
- Administration Office
- 電話番号：+201066634172
- メール：iicpsr_azhar2@hotmail.com
-
主任研究者：
- Ahmed MM Gebreel, MSc.
-
副調査官：
- Ehab HM Hasanin, Prof.
-
副調査官：
- Mohamed S. Abdelall, Prof.
-
-
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
説明
Inclusion Criteria:
- Women aged 20-40 years.
- Body mass index (BMI) between 18 and 30 kg/m².
- Undergoing ICSI treatment using a GnRH antagonist protocol.
- Normal ovarian reserve and expected normal ovarian response.
- AMH between 1.2 - 3.5 ng/ml
- AFC 7-15 follicle.
- First or second ICSI cycle.
Exclusion Criteria:
- Poor ovarian response (Bologna/POSEIDON criteria)
- High ovarian response with a risk of ovarian hyperstimulation syndrome (OHSS) AMH > 3.5 ng/ml or AFC > 15 follicle.
- Polycystic ovary syndrome (PCOS).
- Serum E2 level > 3500 pg/ml at day of triggering.
- Endocrine disorders including diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, or Cushing syndrome.
- Congenital uterine abnormalities.
- Severe systemic diseases affecting fertility outcomes.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Dual Trigger
Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG |
Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG for normal responders patients doing ICSI.
他の名前：
|
|
アクティブコンパレータ：HCG Trigger
HCGTrigger Group: Participants will receive hCG alone. |
hCG Trigger Group: Participants will receive hCG alone the standard for normal responders doing ICSI.
他の名前：
|
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 |
|---|---|---|
|
Oocytes Maturation
時間枠：From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval.
|
Percentage of retrieved oocytes that are at the metaphase II (MII) stage. |
From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of MII oocytes
時間枠：At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up.
|
Number of metaphase II oocytes retrieved |
At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up.
|
|
Number of oocytes retrieved
時間枠：Day of oocyte retrieval (Day 0) after oocyte retrieval.
|
Total number of oocytes retrieved during oocyte retrieval. |
Day of oocyte retrieval (Day 0) after oocyte retrieval.
|
|
Fertilization rate
時間枠：Approximately 16-18 hours after insemination/ICSI
|
Percentage of normally fertilized mature oocytes (2PN) |
Approximately 16-18 hours after insemination/ICSI
|
|
Embryo utilization rate
時間枠：Day 3-5 after oocyte retrieval
|
Percentage of normally fertilized oocytes resulting in embryos suitable for transfer or cryopreservation |
Day 3-5 after oocyte retrieval
|
|
Clinical pregnancy rate
時間枠：Approximately 5-7 weeks after embryo transfer
|
Percentage of embryo transfer cycles resulting in an intrauterine gestational sac with fetal cardiac activity |
Approximately 5-7 weeks after embryo transfer
|
|
Incidence of ovarian hyperstimulation syndrome (OHSS)
時間枠：From the day of trigger administration until 14 days after oocyte retrieval
|
Proportion of participants developing OHSS following controlled ovarian stimulation and oocyte retrieval, classified according to predefined diagnostic/severity criteria. |
From the day of trigger administration until 14 days after oocyte retrieval
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Ehab HM Hasanin, Professor、Obstetrics and Gynecology Department, Al-Azhar University.
- スタディディレクター：Mohamed S. Abdelall, Professor、International Islamic Center for Population Studies and Research
出版物と役立つリンク
一般刊行物
- Zhou X, Guo P, Chen X, Ye D, Liu Y, Chen S. Comparison of dual trigger with combination GnRH agonist and hCG versus hCG alone trigger of oocyte maturation for normal ovarian responders. Int J Gynaecol Obstet. 2018 Jun;141(3):327-331. doi: 10.1002/ijgo.12457. Epub 2018 Feb 21.
- Chung RK, Mancuso AC, Summers KM, Sparks AE, Duran HE, Mejia RB. Dual trigger protocol is an effective in vitro fertilization strategy in both normal and high responders without compromising pregnancy outcomes in fresh cycles. F S Rep. 2021 May 27;2(3):314-319. doi: 10.1016/j.xfre.2021.05.008. eCollection 2021 Sep.
- Gao F, Wang Y, Fu M, Zhang Q, Ren Y, Shen H, Han H. Effect of a "Dual Trigger" Using a GnRH Agonist and hCG on the Cumulative Live-Birth Rate for Normal Responders in GnRH-Antagonist Cycles. Front Med (Lausanne). 2021 May 25;8:683210. doi: 10.3389/fmed.2021.683210. eCollection 2021.
- Albeitawi S, Marar EA, Reshoud FA, Hamadneh J, Hamza R, Alhasan G, Omeish H, Vigano P. Dual trigger with gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves oocyte yield in normal responders on GnRH-antagonist cycles. JBRA Assist Reprod. 2022 Jan 17;26(1):28-32. doi: 10.5935/1518-0557.20210039.
- Yan MH, Cao JX, Hou JW, Jiang WJ, Wang DD, Sun ZG, Song JY. GnRH Agonist and hCG (Dual Trigger) Versus hCG Trigger for Final Oocyte Maturation in Expected Normal Responders With a High Immature Oocyte Rate: Study Protocol for a Randomized, Superiority, Parallel Group, Controlled Trial. Front Endocrinol (Lausanne). 2022 Mar 28;13:831859. doi: 10.3389/fendo.2022.831859. eCollection 2022.
- Andersen CY, Kelsey T, Mamsen LS, Vuong LN. Shortcomings of an unphysiological triggering of oocyte maturation using human chorionic gonadotropin. Fertil Steril. 2020 Aug;114(2):200-208. doi: 10.1016/j.fertnstert.2020.05.022. Epub 2020 Jul 9.
- Eftekhar M, Mojtahedi MF, Miraj S, Omid M. Final follicular maturation by administration of GnRH agonist plus HCG versus HCG in normal responders in ART cycles: An RCT. Int J Reprod Biomed. 2017 Jul;15(7):429-434.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Obs-Gyn-1000/2026/07/0020
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?
IPD プランの説明
raw data and master sheet can be shared
IPD 共有時間枠
After completion of study will be available for one year
IPD 共有アクセス基準
request by email agebreel@hotmail.com
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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