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

NCT ID: NCT03682614

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2019-10-16

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HCG group

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

Group Type: EXPERIMENTAL

HCG

Intervention Type: DRUG

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.

control group

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

Group Type: PLACEBO_COMPARATOR

culture medium

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

culture medium

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fei Gong, Doctor

Role: PRINCIPAL_INVESTIGATOR

Reproductive and Genetic hospital of CITIC-xiangya

Locations

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

Countries

China

Other Identifiers

P2018010

Identifier Type: -

Identifier Source: org_study_id