NCT04064840

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
784

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

August 16, 2019

Last Update Submit

December 5, 2024

Conditions

Subfertility

Keywords

subfertilityIVFFETdual triggerluteal phase supportGonadotrophin releasing hormone agonistlive birth rate

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    delivery after 22 weeks

    after 22 weeks

Secondary Outcomes (7)

  • Pregnancy

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

  • Clinical pregnancy

    6 weeks

  • Biochemical pregnancy

    before 6 weeks

  • Ongoing pregnancy

    8 weeks

  • Implantation rate

    1 day

  • +2 more secondary outcomes

Study Arms (4)

IVF: dual trigger

ACTIVE COMPARATOR

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

Drug: IVF: Decapeptyl and hCG

IVF: hCG trigger

PLACEBO COMPARATOR

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

Drug: IVF: hCG and normal saline

FET: agonist

ACTIVE COMPARATOR

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

Drug: FET: Decapeptyl

FET: control

PLACEBO COMPARATOR

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

Drug: FET: Normal Saline

Interventions

IVF: Decapeptyl and hCGDRUG

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

Also known as: IVF: hCG
IVF: dual trigger
FET: DecapeptylDRUG

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

Also known as: FET: normal saline
FET: agonist
IVF: hCG and normal salineDRUG

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

Also known as: IVF: Decapeptyl and hCG
IVF: hCG trigger
FET: Normal SalineDRUG

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

Also known as: FET: Decapeptyl
FET: control

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Women aged \<43 years at the time of IVF treatment

You may not qualify if:

  • 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
  • FET
  • Women aged \<43 years at the time of IVF treatment
  • Replacing early cleavage embryos or blastocysts after thawing
  • FET in natural cycles
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ernest HY Ng, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernest HY Ng, MD

CONTACT

852-28553400nghye@hku.hk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 22, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2024

Study Completion

March 30, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

CN(1)