Back to resultsEffect of Intrauterine Injection of HCG on Pregnancy Outcome in Repeated Implantation Failure Patients
Primary Purpose
Infertility
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intrauterine injection of HCG
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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
Sites / Locations
- Reproductive & Genetic Hospital of CITIC-XIANGYA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HCG group
Control group
Arm Description
intrauterine injection of HCG before blastocyst transfer
blastocyst transfer
Outcomes
Primary Outcome Measures
clinical pregnancy rate
clinical pregnancy rate
Secondary Outcome Measures
spontaneous abortion rate
spontaneous abortion rate
ectopic pregnancy rate
ectopic pregnancy rate
Full Information
NCT ID
NCT02870855
First Posted
August 14, 2016
Last Updated
January 9, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
1. Study Identification
Unique Protocol Identification Number
NCT02870855
Brief Title
Effect of Intrauterine Injection of HCG on Pregnancy Outcome in Repeated Implantation Failure Patients
Official Title
Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Entry criteria were changed, investigator have registrated a new trials.
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCG group
Arm Type
Experimental
Arm Description
intrauterine injection of HCG before blastocyst transfer
Arm Title
Control group
Arm Type
No Intervention
Arm Description
blastocyst transfer
Intervention Type
Drug
Intervention Name(s)
intrauterine injection of HCG
Intervention Description
intrauterine injection of HCG berore blastocyst transfer
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
clinical pregnancy rate
Time Frame
Until 28 day after embryo transferred
Secondary Outcome Measure Information:
Title
spontaneous abortion rate
Description
spontaneous abortion rate
Time Frame
until 28 day after embryo transferred
Title
ectopic pregnancy rate
Description
ectopic pregnancy rate
Time Frame
until 28 day after embryo transferred
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Intrauterine Injection of HCG on Pregnancy Outcome in Repeated Implantation Failure Patients
We'll reach out to this number within 24 hrs