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The Evolution of Relationship Between Results of Peripheral Blood Test and Outcomes of in Vitro Fertilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103113
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yeh, Chung Shan Medical University

Brief Summary:
The purpose of this study was to assess the relationship between infertility blood test results and outcomes of pregnancy and alive birth of women who underwent with or without intravenous immunoglobulin (IVIG) before in vitro fertilization.

Condition or disease
Infertility, Female Immune Tolerance

Detailed Description:

Study Design (Brief Description)

  1. Inclusion criteria Patients had underwent infertility blood test or treatment in Lee's women hospital
  2. Exclusion criteria No
  3. Endpoint

1. Values of blood test (PTT, IDM, ANA, Lupus, protein-s) 2. Embryo quality 3. Results of intravenous immunoglobulin (IVIG) treatment (pregnancy or not) 4. Alive birth rate

4. Withdraw criteria and rescue medication No 5. Sample Size and Study Duration Sample Size: total 500 women who underwent IVF treatments and tests from Jan. 2007 to Dec. 2010.

Study Duration: from date of IRB agreement to Dec. 2012 6. Please specify objectives of study when collecting extra specimen from participants No more need to collect extra specimen from participants in this study 7. Expected Endpoints of Treatment No 8. Others No

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Division of Infertility, Lee Women's Hospital, Taichung, Taiwan
Actual Study Start Date : April 30, 2012
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : December 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility




Primary Outcome Measures :
  1. implantation rate [ Time Frame: 6-8 weaks after last menstrual ]
    sac and heart bit can be detected after embryo transfer


Secondary Outcome Measures :
  1. live birth rate [ Time Frame: live birth after pregnant ]
    live birth after IVF treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients had underwent infertility blood test and in vitro fertilization treatment in Lee's women hospital
Criteria

Inclusion Criteria:

  • Patients had underwent both infertility blood test and IVF treatment in Lee's women hospital

Exclusion Criteria:

  • No

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): NCT03103113


Sponsors and Collaborators
Yeh
Investigators
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Study Chair: Maw Sheng Lee Lee's Women Hospital, Taichung, Taiwan
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Responsible Party: Yeh, institutional review board, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT03103113    
Other Study ID Numbers: CS12033
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD can be shared after manuscription publication
Additional relevant MeSH terms:
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Infertility
Infertility, Female