Dual Trigger With HCG and GnRH Agonist on Thawed Modified Natural Cycle Embryo Transfer
Impact of Dual Trigger Using Recombinant Human Chorionic Gonadotropin (HCG) and Gonadotropin-releasing Hormone (GnRH) Agonist on Thawed Modified Natural Cycle Outcomes: an Open-label Multi-center Randomized Controlled Trial.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
Study Contact
- Name: william lee
- Phone Number: +886972652396
- Email: wylee@ntuh.gov.tw
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. 24<= Age < 45 patient undergo mNC-FET
Exclusion Criteria:
1. Congenital or acquired uterine abnormalities (uterine malformation, submucosal myoma, intrauterine adhesion or endometrial polyp >1cm)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: dual
GnRH agonist
|
GnRH agonist add to hcg for trigger
|
|
No Intervention: hcg
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implantation
Time Frame: 14 days after embryo transfer
|
Implantation is defined as a positive serum β-hCG (>20 mIU/mL) measured 14 days after embryo transfer.
|
14 days after embryo transfer
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical pregnancy
Time Frame: one week after confirm pregnancy
|
Clinical pregnancy is defined as visualization of a gestational sac on transvaginal ultrasonography one week after pregnancy has been confirmed.
|
one week after confirm pregnancy
|
|
Ongoing pregnancy rate
Time Frame: 5 weeks after confirmed pregnancy
|
An ongoing pregnancy is defined as a viable intrauterine pregnancy with fetal cardiac activity at ≥9 weeks' gestational age.
|
5 weeks after confirmed pregnancy
|
|
Miscarriage rate
Time Frame: before delivery
|
before delivery
|
|
|
Gestational age (weeks) at delivery
Time Frame: delivery
|
Gestational age (weeks) at delivery
|
delivery
|
|
Live birth rate
Time Frame: delivery
|
delivery
|
|
|
Birth weight
Time Frame: delivery
|
Birth weight of the bewborn (kg)
|
delivery
|
|
Presence of significant congenital or medical conditions of the newborn
Time Frame: delivery
|
Presence of significant congenital or medical conditions of the newborn
|
delivery
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Lin MH, Wu FS, Hwu YM, Lee RK, Li RS, Li SH. Dual trigger with gonadotropin releasing hormone agonist and human chorionic gonadotropin significantly improves live birth rate for women with diminished ovarian reserve. Reprod Biol Endocrinol. 2019 Jan 4;17(1):7. doi: 10.1186/s12958-018-0451-x.
- Haas J, Bassil R, Samara N, Zilberberg E, Mehta C, Orvieto R, Casper RF. GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study. Hum Reprod. 2020 Jul 1;35(7):1648-1654. doi: 10.1093/humrep/deaa107.
- Wang Y, Yi YC, Guu HF, Chen YF, Kung HF, Chang JC, Chen LY, Chuan ST, Chen MJ. GnRH agonist-only trigger, compared to dual trigger, reduces oocyte retrieval rate in high responders without affecting cumulative live birth rate. Front Endocrinol (Lausanne). 2024 Aug 20;15:1461317. doi: 10.3389/fendo.2024.1461317. eCollection 2024.
- Halim B, Lubis HP. Dual trigger with gonadotropin-releasing hormone agonist and recombinant human chorionic gonadotropin improves the outcome of intrauterine insemination. Obstet Gynecol Sci. 2022 Mar;65(2):207-214. doi: 10.5468/ogs.21275. Epub 2022 Feb 21.
- Yildirim Kopuk S, Ece Utkan Korun Z, Yuceturk A, Karaosmanoglu O, Yazicioglu C, Tiras B, Cakiroglu Y. Does dual trigger improve euploidy rate in normoresponder? A cross-sectional study. Int J Reprod Biomed. 2023 May 12;21(5):395-402. doi: 10.18502/ijrm.v21i5.13473. eCollection 2023 May.
- He Z, Liu Y, Huang N, Liu X, Zeng L, Lian Y, Li R, Chi H. Dual trigger versus human chorionic gonadotropin trigger for blastocyst quality and cumulative live birth. J Assist Reprod Genet. 2024 Dec;41(12):3445-3453. doi: 10.1007/s10815-024-03293-5. Epub 2024 Nov 16.
- Hu KL, Wang S, Ye X, Zhang D, Hunt S. GnRH agonist and hCG (dual trigger) versus hCG trigger for follicular maturation: a systematic review and meta-analysis of randomized trials. Reprod Biol Endocrinol. 2021 Jun 1;19(1):78. doi: 10.1186/s12958-021-00766-5.
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 202409081MINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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