Effect of Intrauterine Injection of HCG on 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

Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive technology, many studies have considered that the cause of two-thirds of implant failure is the decreased endometrial receptivity. Human chorionic gonadotropin (hCG) is an early pre-plant signal molecule secreted by the embryo, it can promote endometrial proliferation, increase blood flow and promote embryonic adhesion and inhibit self-regulate 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• Status: Withdrawn
• Conditions: Infertility
• Intervention / Treatment: Drug: intrauterine injection of HCG

• Study Type: Interventional
• 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: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women with unexplained RIF(two to four previous embryo transfers without achieving pregnancy);
• age<36 years;
• frozen embryo transfer cycles

Exclusion Criteria:

• polycystic ovary syndrome
• uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum)
• intrauterine adhesions
• endometriosis
• adenomyosis
• hydrosalpinx
• uterine fibroids (submucosal fibroids, non-mucosal fibroids > 4 cm and / or endometrial pressure)
• thydroid dysfunction and hyperprolactinemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCG group; intrauterine injection of HCG before blastocyst transfer	Drug: intrauterine injection of HCG; intrauterine injection of HCG berore blastocyst transfer
No Intervention: Control group; blastocyst transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	clinical pregnancy rate	Until 28 day after embryo transferred

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spontaneous abortion rate	spontaneous abortion rate	until 28 day after embryo transferred
ectopic pregnancy rate	ectopic pregnancy rate	until 28 day after embryo transferred

Collaborators and Investigators

• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: August 14, 2016
• First Submitted That Met QC Criteria: August 14, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: KYXM-201604

Drug and device information, study documents

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