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

NCT02870855 | Withdrawn

• 1 other identifier: KYXM-201604
• Study Type: interventional
• Target: N/A
• 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 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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  clinical pregnancy rate

  Until 28 day after embryo transferred

Secondary Outcomes (2)

• spontaneous abortion rate

  until 28 day after embryo transferred

• ectopic pregnancy rate

  until 28 day after embryo transferred

Study Arms (2)

HCG group

EXPERIMENTAL

intrauterine injection of HCG before blastocyst transfer

Drug: intrauterine injection of HCG

Control group

NO INTERVENTION

blastocyst transfer

Interventions

intrauterine injection of HCG DRUG

intrauterine injection of HCG berore blastocyst transfer

HCG group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

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

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: August 17, 2016
• Study Start: July 28, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)