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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HCG
culture medium
Sponsored by
Reproductive & Genetic Hospital of CITIC-Xiangya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Reproductive & Genetic Hospital of CITIC-XIANGYA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HCG group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

clinical pregnancy rate

Secondary Outcome Measures

clinical implantation rate
ongoing pregnancy rate
ectopic pregnancy rate
abortion rate

Full Information

First Posted
September 18, 2018
Last Updated
January 10, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
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1. Study Identification

Unique Protocol Identification Number
NCT03682614
Brief Title
Effect of Intrauterine Injection of HCG on Clinical 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 With Normal Pathohistological Stage --Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
August 18, 2019 (Actual)
Study Completion Date
October 16, 2019 (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

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 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.

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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCG group
Arm Type
Experimental
Arm Description
All patients will accept HCG 500IU intrauterine injection 2 days before blastocyte transfer
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
All patients will accept same dose of culture medium intrauterine injection 2 days before blastocyte transfer
Intervention Type
Drug
Intervention Name(s)
HCG
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
culture medium
Intervention Description
The placebo group will accept 40 μl of culture medium injection into the uterine cavity 2 days before the blastocyst transfer.
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Time Frame
28 days after blastocyst transfer
Secondary Outcome Measure Information:
Title
clinical implantation rate
Time Frame
28 days after blastocyst transfer
Title
ongoing pregnancy rate
Time Frame
70 days after blastocyst transfer
Title
ectopic pregnancy rate
Time Frame
within 3 months after blastocyst transfer
Title
abortion rate
Time Frame
within 28 weeks after blastocyst transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Gong, Doctor
Organizational Affiliation
Reproductive and Genetic hospital of CITIC-xiangya
Official's Role
Principal Investigator
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

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

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