NCT07269392

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
45mo left

Started Jan 2026

Longer than P75 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Dec 2029

First Submitted

Initial submission to the registry

September 21, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 16, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

September 21, 2025

Last Update Submit

December 8, 2025

Conditions

Embryo TransferIn Vitro Fertilization (IVF)

Outcome Measures

Primary Outcomes (1)

  • Implantation

    Implantation is defined as a positive serum β-hCG (\>20 mIU/mL) measured 14 days after embryo transfer.

    14 days after embryo transfer

Secondary Outcomes (7)

  • Clinical pregnancy

    one week after confirm pregnancy

  • Ongoing pregnancy rate

    5 weeks after confirmed pregnancy

  • Miscarriage rate

    before delivery

  • Gestational age (weeks) at delivery

    delivery

  • Live birth rate

    delivery

  • +2 more secondary outcomes

Study Arms (2)

dual

EXPERIMENTAL

GnRH agonist

Drug: GnRH agonist

hcg

NO INTERVENTION

hcg

Interventions

GnRH agonistDRUG

GnRH agonist add to hcg for trigger

dual

Eligibility Criteria

Age25 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 24\<= Age \< 45 patient undergo mNC-FET

You may not qualify if:

  • \. Congenital or acquired uterine abnormalities (uterine malformation, submucosal myoma, intrauterine adhesion or endometrial polyp \>1cm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 32563188BACKGROUND

  • 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.

    PMID: 30609935BACKGROUND

  • 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.

    PMID: 39229374BACKGROUND

  • 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.

    PMID: 35184525BACKGROUND

  • 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.

    PMID: 37362090BACKGROUND

  • 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.

    PMID: 39549203BACKGROUND

  • 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.

    PMID: 34059045BACKGROUND

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

william lee

CONTACT

+886972652396wylee@ntuh.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2025

First Posted

December 8, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

December 16, 2025

Record last verified: 2025-09