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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ahmed MM Gebreel, MSc
- 전화번호: +201092576506
- 이메일: agebreel@hotmail.com
연구 장소
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Cairo Governorate
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Cairo, Cairo Governorate, 이집트
- 모병
- ART Unit, International Islamic Center for Population Studies and Research, Al-Azhar University
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연락하다:
- Administration Office
- 전화번호: +201066634172
- 이메일: iicpsr_azhar2@hotmail.com
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수석 연구원:
- Ahmed MM Gebreel, MSc.
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부수사관:
- Ehab HM Hasanin, Prof.
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부수사관:
- Mohamed S. Abdelall, Prof.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
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활성 비교기: HCG Trigger
HCGTrigger Group: Participants will receive hCG alone. |
hCG Trigger Group: Participants will receive hCG alone the standard for normal responders doing ICSI.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oocytes Maturation
기간: From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval.
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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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of MII oocytes
기간: 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
기간: Day of oocyte retrieval (Day 0) after oocyte retrieval.
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Total number of oocytes retrieved during oocyte retrieval. |
Day of oocyte retrieval (Day 0) after oocyte retrieval.
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Fertilization rate
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Ehab HM Hasanin, Professor, Obstetrics and Gynecology Department, Al-Azhar University.
- 연구 책임자: Mohamed S. Abdelall, Professor, International Islamic Center for Population Studies and Research
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Obs-Gyn-1000/2026/07/0020
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
raw data and master sheet can be shared
IPD 공유 기간
After completion of study will be available for one year
IPD 공유 액세스 기준
request by email agebreel@hotmail.com
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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