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

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ClinicalTrials.gov Identifier: NCT03682614
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: HCG Other: culture medium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: HCG group
All patients will accept HCG 500IU intrauterine injection 2 days before blastocyte transfer
Drug: HCG
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.

Placebo Comparator: control group
All patients will accept same dose of culture medium intrauterine injection 2 days before blastocyte transfer
Other: culture medium
The placebo group will accept 40 μl of culture medium injection into the uterine cavity 2 days before the blastocyst transfer.




Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 28 days after blastocyst transfer ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682614


Contacts
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Contact: Huijun Chen, Master 0731-82355100 853747455@qq.com

Locations
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China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA Recruiting
Changsha, Hunan, China, 410000
Contact: Huijun Chen    +86-731-82355100    853747455@qq.com   
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya

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Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT03682614     History of Changes
Other Study ID Numbers: P2018010
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female