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

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ClinicalTrials.gov Identifier: NCT02870855
Recruitment Status : Withdrawn (Entry criteria were changed, investigator have registrated a new trials.)
First Posted : August 17, 2016
Last Update Posted : December 17, 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 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.

Condition or disease Intervention/treatment Phase
Infertility Drug: intrauterine injection of HCG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

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



Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: Until 28 day after embryo transferred ]
    clinical pregnancy rate


Secondary Outcome Measures :
  1. spontaneous abortion rate [ Time Frame: until 28 day after embryo transferred ]
    spontaneous abortion rate

  2. ectopic pregnancy rate [ Time Frame: until 28 day after embryo transferred ]
    ectopic pregnancy rate



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT02870855


Locations
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China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, China, 410000
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya

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Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT02870855     History of Changes
Other Study ID Numbers: KYXM-201604
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: December 17, 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