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.
研究概览
地位
详细说明
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).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ahmed MM Gebreel, MSc
- 电话号码：+201092576506
- 邮箱：agebreel@hotmail.com
学习地点
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Cairo Governorate
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Cairo、Cairo Governorate、埃及
- 招聘中
- ART Unit, International Islamic Center for Population Studies and Research, Al-Azhar University
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接触：
- Administration Office
- 电话号码：+201066634172
- 邮箱：iicpsr_azhar2@hotmail.com
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首席研究员：
- Ahmed MM Gebreel, MSc.
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副研究员：
- Ehab HM Hasanin, Prof.
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副研究员：
- Mohamed S. Abdelall, Prof.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
其他名称：
|
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有源比较器：HCG Trigger
HCGTrigger Group: Participants will receive hCG alone. |
hCG Trigger Group: Participants will receive hCG alone the standard for normal responders doing ICSI.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oocytes Maturation
大体时间：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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of MII oocytes
大体时间：At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up.
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Number of metaphase II oocytes retrieved |
At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up.
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|
Number of oocytes retrieved
大体时间：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
大体时间：Approximately 16-18 hours after insemination/ICSI
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Percentage of normally fertilized mature oocytes (2PN) |
Approximately 16-18 hours after insemination/ICSI
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|
Embryo utilization rate
大体时间：Day 3-5 after oocyte retrieval
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Percentage of normally fertilized oocytes resulting in embryos suitable for transfer or cryopreservation |
Day 3-5 after oocyte retrieval
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Clinical pregnancy rate
大体时间：Approximately 5-7 weeks after embryo transfer
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Percentage of embryo transfer cycles resulting in an intrauterine gestational sac with fetal cardiac activity |
Approximately 5-7 weeks after embryo transfer
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Incidence of ovarian hyperstimulation syndrome (OHSS)
大体时间：From the day of trigger administration until 14 days after oocyte retrieval
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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
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合作者和调查者
调查人员
- 研究主任：Ehab HM Hasanin, Professor、Obstetrics and Gynecology Department, Al-Azhar University.
- 研究主任：Mohamed S. Abdelall, Professor、International Islamic Center for Population Studies and Research
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Obs-Gyn-1000/2026/07/0020
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
raw data and master sheet can be shared
IPD 共享时间框架
After completion of study will be available for one year
IPD 共享访问标准
request by email agebreel@hotmail.com
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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