Gonadotrophin Releasing Hormone Agonist for Dual Trigger in in Vitro Fertilization and for Luteal Phase Support in Frozen-thawed Embryo Transfer
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 784
- Locations
- 1
- Primary Endpoint
- Live birth rate
Study Overview
Brief Summary
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.
Detailed Description
Trial design:
A randomised, double-blinded and placebo controlled trial will be performed in IVF cycles and another randomised, double-blinded and placebo controlled trial will be performed in FET cycles.
Treatment of subjects:
IVF Women being scheduled for IVF at Department of Obstetrics & Gynaecology of Kwong Wah Hospital and Queen Mary Hospital will be assessed for eligibility. Eligible women will be recruited for the study and each woman will only be included in the study. Informed written consent will be obtained after counseling.
All techniques of IVF including ovarian stimulation, harvesting of oocytes, insemination with specially prepared sperm and embryo culture in the laboratory will be according to local protocols. Women will receive ovarian stimulation using antagonist protocol. Ultrasound scanning will be arranged on day 2-3 of menses for the antral follicle counts and to exclude the presence of ovarian cyst. Oestradiol and progesterone concentration will be checked and if they are basal, ovarian stimulation with gonadotropin injections will be given. GnRH antagonist will be started on day 6 of ovarian stimulation. Regular ultrasound monitoring will be performed to monitor the growth of follicles. Adjustment of the gonadotropin dosage is corresponding to the number and size of follicles.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria:
- •- Women aged <43 years at the time of IVF treatment
Exclusion Criteria
- •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
- •Inclusion criteria:
- •Women aged <43 years at the time of IVF treatment
- •Replacing early cleavage embryos or blastocysts after thawing
- •FET in natural cycles
- •Exclusion criteria:
- •Frozen early cleavage embryos thawed and cultured to blastocysts prior to transfer as requested by the patient
- •Preimplantation genetic diagnosis treatment
- •Use of donor oocytes or donor embryos
- •Hydrosalpinx shown on pelvic scanning and not surgically treated
Arms & Interventions
IVF: dual trigger
When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and decapeptyl 0.2mg will be injected subcutaneously.
Intervention: IVF: Decapeptyl and hCG (Drug)
IVF: hCG trigger
When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and normal saline will be injected subcutaneously.
Intervention: IVF: hCG and normal saline (Drug)
FET: agonist
On the day of FET, decapeptyl 0.1 mg will be injected subcutaneously.
Intervention: FET: Decapeptyl (Drug)
FET: control
On the day of FET, normal saline will be injected subcutaneously.
Intervention: FET: Normal Saline (Drug)
Outcomes
Primary Outcomes
Live birth rate
Time Frame: after 22 weeks
delivery after 22 weeks
Secondary Outcomes
- Pregnancy(18 days after the dual or hCG trigger in IVF cycles or the LH surge in FET cycles)
- Biochemical pregnancy(before 6 weeks)
- Implantation rate(1 day)
- Clinical pregnancy(6 weeks)
- Adverse events(8 weeks)
- Neonatal outcome(40 weeks)
- Ongoing pregnancy(8 weeks)