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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: HCG; Other: culture medium

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Reproductive & Genetic hospital Of CITIC-Xiangya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical pregnancy rate	28 days after blastocyst transfer

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
• Investigators: Principal Investigator: Fei Gong, Doctor, Reproductive and Genetic Hospital of CITIC-XIANGYA

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2018
• Primary Completion (ACTUAL): August 18, 2019
• Study Completion (ACTUAL): October 16, 2019

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (ACTUAL): September 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: P2018010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No