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Embryo Transfer With Self-spent Culture Medium

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ClinicalTrials.gov Identifier: NCT03728140
Recruitment Status : Completed
First Posted : November 1, 2018
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Bin Wu, Jinan Central Hospital

Brief Summary:
Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two?

Condition or disease Intervention/treatment Phase
in Vitro Fertilization Procedure: Self-spent Culture Medium Not Applicable

Detailed Description:

Although some metabolites are present in self-spent culture medium, there are some embryonic exocrine factors secreted by embryo.These factors may have a positive impact on embryo implantation and subsequent development. So it is necessary to compare the two ways of embryo transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo transfer process.

The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Can Embryo Transfer With Self-spent Culture Medium Improve Clinical Pregnancy Outcomes in Vitro Fertilization - Embryo Transfer Process?
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Self-spent Culture Medium
Changing embryo transfer solution with self-spent culture medium
Procedure: Self-spent Culture Medium
Replace embryo transfer solution with Self-spent culture medium in IVF-ET.

No Intervention: New Culture Medium
embryo transfer with new culture medium in IVF-ET



Primary Outcome Measures :
  1. Number of Participants Pregnant After 4 Weeks [ Time Frame: 4 weeks ]
    Observe the clinical pregnancy rate under different embryo transfer methods

  2. Live Birth [ Time Frame: 40 weeks ]
    Observe the live birth rate under different embryo transfer methods



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women in childbearing age intend to do IVF
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infertility female patients with tubal factors,
  • Infertile female patients with spouse factors

Exclusion Criteria:

  • Intrauterine adhesions,
  • Endometriosis,
  • Primary ovarian insufficiency,
  • Infectious disease

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): NCT03728140


Locations
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China, Shandong
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, China, 250013
Sponsors and Collaborators
Bin Wu
Investigators
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Study Director: Yingchun zhang, Dr Jinan Central Hospital
  Study Documents (Full-Text)

Documents provided by Bin Wu, Jinan Central Hospital:
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Responsible Party: Bin Wu, Reproductive medcine, Jinan Central Hospital
ClinicalTrials.gov Identifier: NCT03728140    
Other Study ID Numbers: JianCH-RM001
First Posted: November 1, 2018    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bin Wu, Jinan Central Hospital:
Embryo Transfer