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

ConditionSubfertility
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorThe University of Hong Kong

About this trial

The objectives of this study are to compare the efficacy of the dual trigger group vs the hCG trigger group on the live birth rate in women undergoing IVF and the efficacy of the agonist in LP group vs the placebo group on the live birth rate in women undergoing FET.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Preimplantation genetic diagnosis treatment

Use of donor oocytes or donor embryos

Hydrosalpinx shown on pelvic scanning and not surgically treated

Women at risk of OHSS

Trial design

Design model

Parallel

Treatments tested in this trial

  • IVF: Decapeptyl and hCG

    Drug

    When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and decapeptyl 0.2mg will be injected subcutaneously.

  • FET: Decapeptyl

    Drug

    On the day of FET, decapeptyl 0.1 mg will be injected subcutaneously.

  • IVF: hCG and normal saline

    Drug

    When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and normal saline will be injected subcutaneously.

  • FET: Normal Saline

    Drug

    On the day of FET, normal saline will be injected subcutaneously.

Treatment groups

784 Participants
are divided into 4 treatment groups
Group A: IVF: dual triggerActive comparator 1 intervention
Group B: IVF: hCG triggerPlacebo comparator 1 intervention
Group C: FET: agonistActive comparator 1 intervention
Group D: FET: controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Live birth rate

delivery after 22 weeks

Time frame
after 22 weeks

Secondary outcomes

1

Pregnancy

positive urine pregnancy test

Time frame
18 days after the dual or hCG trigger in IVF cycles or the LH surge in FET cycles
2

Clinical pregnancy

presence of intrauterine gestational sac on ultrasound

Time frame
6 weeks
3

Biochemical pregnancy

positive urine pregnancy test not followed by clinical pregnancy

Time frame
before 6 weeks
4

Ongoing pregnancy

viable pregnancy beyond gestation 8 weeks

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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