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

NCT03682614 | Completed

• 1 other identifier: P2018010
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  28 days after blastocyst transfer

Secondary Outcomes (4)

• 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

Study Arms (2)

HCG group

EXPERIMENTAL

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

Drug: HCG

control group

PLACEBO COMPARATOR

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

Other: culture medium

Interventions

HCG 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.

HCG group

culture medium OTHER

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

control group

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%
• endometrial CD138 positive cell
• natural cycle frozen embryo transfer
• frozen blastocysts (≥4BC) embryos ≥ 1

You may not qualify if:

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

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Infertility

Interventions

Culture Media

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Study Officials

• Fei Gong, Doctor

  Reproductive and Genetic hospital of CITIC-xiangya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 24, 2018
• Study Start: December 10, 2018
• Primary Completion: August 18, 2019
• Study Completion: October 16, 2019
• Last Updated: January 11, 2022

Record last verified: 2019-11

Locations

CN (1)