Skip to main content
OpenTrials
Completed

NCT Number: NCT03682614

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

culture medium

Other

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

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 28 days after blastocyst transfer

Secondary outcomes

  1. clinical implantation rate

    Time frame: 28 days after blastocyst transfer

  2. ongoing pregnancy rate

    Time frame: 70 days after blastocyst transfer

  3. ectopic pregnancy rate

    Time frame: within 3 months after blastocyst transfer

  4. abortion rate

    Time frame: within 28 weeks after blastocyst transfer

Sponsors and collaborators

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.