In Vitro Fertilization (IVF)Phase 4NCT07269392
Dual Trigger With HCG and GnRH Agonist on Thawed Modified Natural Cycle Embryo Transfer
A Phase 4 study testing GnRH agonist in people with In Vitro Fertilization (IVF) and Embryo Transfer, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In Vitro Fertilization (IVF), Embryo Transfer
- What is being tested?
- GnRH agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. 24<= Age < 45 patient undergo mNC-FET
Who cannot join
- 1. Congenital or acquired uterine abnormalities (uterine malformation, submucosal myoma, intrauterine adhesion or endometrial polyp >1cm)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- In Vitro Fertilization (IVF), Embryo Transfer
- Being tested
- GnRH agonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonistDrug
GnRH agonist add to hcg for trigger
| Study group | Role | What they receive |
|---|---|---|
| dual | Experimental | GnRH agonist Receives: Drug: GnRH agonist |
| hcg | No intervention | hcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation
Implantation is defined as a positive serum β-hCG (>20 mIU/mL) measured 14 days after embryo transfer.
Measured: 14 days after embryo transfer
Secondary outcomes (7)
Clinical pregnancy
Clinical pregnancy is defined as visualization of a gestational sac on transvaginal ultrasonography one week after pregnancy has been confirmed.
Measured: one week after confirm pregnancy
Ongoing pregnancy rate
An ongoing pregnancy is defined as a viable intrauterine pregnancy with fetal cardiac activity at ≥9 weeks' gestational age.
Measured: 5 weeks after confirmed pregnancy
Miscarriage rate
Measured: before delivery
Gestational age (weeks) at delivery
Gestational age (weeks) at delivery
Measured: delivery
Live birth rate
Measured: delivery
Birth weight
Birth weight of the bewborn (kg)
Measured: delivery
Presence of significant congenital or medical conditions of the newborn
Presence of significant congenital or medical conditions of the newborn
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for In Vitro Fertilization (IVF)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269392
- Sponsor's protocol ID
- 202409081MINB
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32563188Lin 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.
PubMed 30609935Wang 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.
PubMed 39229374Halim 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.
PubMed 35184525Yildirim 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.
PubMed 37362090He 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.
PubMed 39549203Hu 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.
PubMed 34059045
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07269392
- Acronym / sponsor ID
- 202409081MINB
- Conditions
- In Vitro Fertilization (IVF), Embryo Transfer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dual | Experimental | Drug: GnRH agonistGnRH agonist |
| hcg | No intervention | –hcg |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. 24<= Age < 45 patient undergo mNC-FET
Key exclusion criteria (1 listed)
- 1. Congenital or acquired uterine abnormalities (uterine malformation, submucosal myoma, intrauterine adhesion or endometrial polyp >1cm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GnRH agonistGnRH agonist add to hcg for trigger | Drug | dual |
Primary outcome
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.
7 secondary outcomes
Clinical pregnancy
Time frame: one week after confirm pregnancy
Ongoing pregnancy rate
Time frame: 5 weeks after confirmed pregnancy
Miscarriage rate
Time frame: before delivery
Gestational age (weeks) at delivery
Time frame: delivery
Live birth rate
Time frame: delivery
Birth weight
Time frame: delivery
Presence of significant congenital or medical conditions of the newborn
Time frame: delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 32563188Haas 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.
- Background: PubMed 30609935Lin 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.
- Background: PubMed 39229374Wang 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.
- Background: PubMed 35184525Halim 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.
- Background: PubMed 37362090Yildirim 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.
- Background: PubMed 39549203He 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.
- Background: PubMed 34059045Hu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GnRH agonist in people with In Vitro Fertilization (IVF) and Embryo Transfer, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact william lee (+886972652396, wylee@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation (time frame: 14 days after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07269392, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.