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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682614
• Other study ID #: P2018010
• Status: Completed
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: October 16, 2019

Study information

• Verified date: November 2019
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 16, 2019
• Est. primary completion date: August 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

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

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate		28 days after blastocyst transfer
Secondary	clinical implantation rate		28 days after blastocyst transfer
Secondary	ongoing pregnancy rate		70 days after blastocyst transfer
Secondary	ectopic pregnancy rate		within 3 months after blastocyst transfer
Secondary	abortion rate		within 28 weeks after blastocyst transfer