Effect of Intrauterine Injection of HCG on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients

Sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya (Other)

Overall Status

Completed

CT.gov ID

NCT03682614

Collaborator

(none)

Enrollment

Location

Arms

10.2

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive technology, many studies have considered that the cause of two-thirds of implantation failure is the decreased endometrial receptivity. After exclude some major local immune factors(NK,CD138 cells) and implantation window out of phase, There are still a part of patients infertile .Human chorionic gonadotropin (hCG) is an early pre-implantation signal molecule secreted by the embryo, it can promote endometrial proliferation, increase blood flow and promote embryonic adhesion and inhibit self-regulated apoptosis of trophoblast cells. Previous studies showed that: intrauterine injection of HCG before embryo transfer can improve clinical outcomes in IVF/Intracytoplasmic sperm injection(ICSI). But some studies found that the intrauterine injection of HCG can not significantly improve the success rate of blastocyst transfer, and the reason may be the intrauterine injection of HCG time is too late to significantly increase the implantation rate. Would ahead of intrauterine injection of HCG be more effective? Thus, the patients of repeated implantation frozen embryo cycle according to the random principle accepted two kinds of transplants ways: ①intrauterine injection of HCG before blastocyst transfer; ②blastocyst transfer. Try to understand whether intrauterine injection of HCG can significantly improve the clinical pregnancy rate of blastocyst transfer in repeated implantation failure patients.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: HCG Other: culture medium	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients With Normal Pathohistological Stage --Pilot Study

Actual Study Start Date :

Dec 10, 2018

Actual Primary Completion Date :

Aug 18, 2019

Actual Study Completion Date :

Oct 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HCG group All patients will accept HCG 500IU intrauterine injection 2 days before blastocyte transfer	Drug: HCG we will use the catheter to pass through the cervix, and after that, the experiment Group will accept 40 μl 500 IU HCG injection into the uterine cavity 2 days before the blastocyst transfer.
Placebo Comparator: control group All patients will accept same dose of culture medium intrauterine injection 2 days before blastocyte transfer	Other: culture medium The placebo group will accept 40 μl of culture medium injection into the uterine cavity 2 days before the blastocyst transfer.

Arm

Intervention/Treatment

Experimental: HCG group

All patients will accept HCG 500IU intrauterine injection 2 days before blastocyte transfer

Drug: HCG

we will use the catheter to pass through the cervix, and after that, the experiment Group will accept 40 μl 500 IU HCG injection into the uterine cavity 2 days before the blastocyst transfer.

Placebo Comparator: control group

All patients will accept same dose of culture medium intrauterine injection 2 days before blastocyte transfer

Other: culture medium

The placebo group will accept 40 μl of culture medium injection into the uterine cavity 2 days before the blastocyst transfer.

Outcome Measures

Primary Outcome Measures

clinical pregnancy rate [28 days after blastocyst transfer]

Secondary Outcome Measures

clinical implantation rate [28 days after blastocyst transfer]
ongoing pregnancy rate [70 days after blastocyst transfer]
ectopic pregnancy rate [within 3 months after blastocyst transfer]
abortion rate [within 28 weeks after blastocyst transfer]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 36 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

repeated implantation failure patients: ≥ 3 times IVF-embryo transfer failed to help pregnancy (biochemical or non-pregnant)
age ≤36 years old
normal histopathological stage (+5-7)
endometrial NK cell <4.5%
0 endometrial CD138 positive cell
natural cycle frozen embryo transfer
frozen blastocysts (≥4BC) embryos ≥ 1

Exclusion Criteria:

Scar uterus (diverticulum or incision false lumen after cesarean section)
intrauterine adhesions
untreated hydrosalpinx
adenomyosis (endometrial displacement)
endometritis
uterine fibroids compress the endometrium

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan	China	410000

Sponsors and Collaborators

Reproductive & Genetic Hospital of CITIC-Xiangya

Investigators

Principal Investigator: Fei Gong, Doctor, Reproductive and Genetic hospital of CITIC-xiangya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reproductive & Genetic Hospital of CITIC-Xiangya

ClinicalTrials.gov Identifier:

NCT03682614

Other Study ID Numbers:

P2018010

First Posted:

Sep 24, 2018

Last Update Posted:

Jan 11, 2022

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Jan 11, 2022