Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064840
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Subfertility Drug: IVF: Decapeptyl and hCG Drug: FET: Decapeptyl Drug: IVF: hCG and normal saline Drug: FET: Normal Saline Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gonadotrophin Releasing Hormone Agonist for Dual Trigger in in Vitro Fertilization and for Luteal Phase Support in Frozen-thawed Embryo Transfer
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2023

Arm Intervention/treatment
Active Comparator: 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.
Drug: IVF: Decapeptyl and hCG
When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and decapeptyl 0.2mg will be injected subcutaneously.
Other Name: IVF: hCG

Placebo Comparator: IVF: hCG trigger
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
When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and normal saline will be injected subcutaneously.
Other Name: IVF: Decapeptyl and hCG

Active Comparator: FET: agonist
On the day of FET, decapeptyl 0.1 mg will be injected subcutaneously.
Drug: FET: Decapeptyl
On the day of FET, decapeptyl 0.1 mg will be injected subcutaneously.
Other Name: FET: normal saline

Placebo Comparator: FET: control
On the day of FET, normal saline will be injected subcutaneously.
Drug: FET: Normal Saline
On the day of FET, normal saline will be injected subcutaneously.
Other Name: FET: Decapeptyl




Primary Outcome Measures :
  1. Live birth rate [ Time Frame: after 22 weeks ]
    delivery after 22 weeks


Secondary Outcome Measures :
  1. Pregnancy [ Time Frame: 18 days after the dual or hCG trigger in IVF cycles or the LH surge in FET cycles ]
    positive urine pregnancy test

  2. Clinical pregnancy [ Time Frame: 6 weeks ]
    presence of intrauterine gestational sac on ultrasound

  3. Biochemical pregnancy [ Time Frame: before 6 weeks ]
    positive urine pregnancy test not followed by clinical pregnancy

  4. Ongoing pregnancy [ Time Frame: 8 weeks ]
    viable pregnancy beyond gestation 8 weeks

  5. Implantation rate [ Time Frame: 1 day ]
    number of gestational sacs per embryo transferred

  6. Adverse events [ Time Frame: 8 weeks ]
    Ovarian hyperstimulation syndrome

  7. Neonatal outcome [ Time Frame: 40 weeks ]
    Birth weight of babies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

IVF

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

FET

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064840


Contacts
Layout table for location contacts
Contact: Ernest HY Ng, MD 852-28553400 nghye@hku.hk

Locations
Layout table for location information
China, Hong Kong
Department of Obstetrics and Gynaecology Recruiting
Hong Kong, Hong Kong, China
Contact: Ernest HY NG, MD    852-22553400    nghye@hku.hk   
Principal Investigator: Ernest HY NG, MD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Ernest HY Ng, MD The University of Hong Kong
Layout table for additonal information
Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04064840    
Other Study ID Numbers: UW 18-393
06171626 ( Other Grant/Funding Number: HMRF )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The University of Hong Kong:
subfertility
IVF
FET
dual trigger
luteal phase support
Gonadotrophin releasing hormone agonist
live birth rate
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents