Actively Recruiting

Phase 3
Age: 18Years - 42Years
FEMALE
ID04064840

Gonadotrophin Releasing Hormone Agonist for Dual Trigger in IVF and for Luteal Phase Support in Frozen-thawed Embryo Transfer

Led by The University of Hong Kong · Updated on 2026-05-15

784

Participants Needed

1

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two methods to improve live birth rates in women undergoing IVF and frozen embryo transfer (FET). The study evaluates the use of a dual trigger (GnRH agonist plus hCG) versus hCG alone for IVF, and GnRH agonist versus placebo for luteal phase support in FET. This is a randomized, double-blinded, placebo-controlled Phase 3 trial focusing on women with subfertility. Women undergoing IVF will receive ovarian stimulation and monitoring before being randomly assigned to receive either the dual trigger (recombinant hCG with decapeptyl) or hCG with saline injection. Egg retrieval follows 36 hours later, with embryo transfer occurring 2 or 5 days afterward. In the FET group, women will be randomized to receive either decapeptyl or saline on the day of embryo transfer, with embryos transferred 3 or 6 days after the LH surge. Both groups receive standard embryo culture and transfer protocols. Participants will have pregnancy tests 18 days after treatment, followed by ultrasounds to confirm pregnancy and fetal viability. Data on pregnancy outcomes, including delivery details and complications, will be collected from hospital records or private obstetricians. The study closely tracks live birth rates and other pregnancy outcomes, with follow-up continuing through delivery and neonatal assessments.

CONDITIONS

Brief Title

GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET

Who Can Participate

Age: 18Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged under 43 years at the time of IVF treatment
  • Women replacing early cleavage embryos or blastocysts after thawing in frozen embryo transfer
  • Frozen embryo transfer performed in natural cycles
Not Eligible

You will not qualify if you...

  • Use of preimplantation genetic diagnosis treatment
  • Use of donor oocytes or donor embryos
  • Presence of hydrosalpinx on pelvic scanning that has not been surgically treated
  • Women at risk of ovarian hyperstimulation syndrome (OHSS)
  • Frozen early cleavage embryos thawed and cultured to blastocysts before transfer as requested by the patient in frozen embryo transfer cycles

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to ovarian stimulation cycle length plus embryo transfer and 2 weeks of luteal phase support for IVF; FET cycle length up to embryo transfer day

Participants undergoing IVF receive ovarian stimulation, followed by a dual trigger or hCG trigger injection when follicles reach 18 mm, then egg retrieval and embryo transfer. Participants undergoing frozen embryo transfer (FET) receive an injection on the day of transfer after ovulation detection, followed by embryo transfer.

Multiple visits for ovarian stimulation monitoring and 1 to 2 visits for embryo transfer procedures

Follow-up

Duration - Up to delivery (approximately 40 weeks from embryo transfer)

Participants have a pregnancy test about 18 days after the trigger or LH surge. If pregnant, ultrasound is performed 2 weeks later to confirm viability, with ongoing monitoring up to delivery.

1 visit for pregnancy test, 1 ultrasound visit 2 weeks later, plus routine antenatal visits if pregnancy confirmed

Trial Site Locations

Total: 1 location

1

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

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Research Team

E

Ernest HY Ng, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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