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A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome

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ClinicalTrials.gov Identifier: NCT03594201
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

Brief Summary:
The investigators plan to retrospectively analyze clinical data from 14,189 fresh ICSI cycles in Reproductive and Genetic Hospital of CITIC-Xiangya from January 2016 to December 2017.The investigators will regard total progressive sperm number of 2 x 10^6 after pretreatment as the boundary value, and will divide total progressive sperm number of 2 x 10^6 after pretreatment into 2 x 10^6 or higher and < 2 x 10^6 groups, and will further divide < 2 x 10^6 group into: = 0, (0,10^6], (10^6, 2 x 10^6) three groups. Propensity score matching will be used to balance the baseline data between four groups. The matching variables are age, female BMI, AFC, AMH and ICSI.

Condition or disease Intervention/treatment
Sperm Count, Low Reproductive Sterility Other: semen pretreatment

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Study Type : Observational
Actual Enrollment : 12215 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : January 3, 2018

Group/Cohort Intervention/treatment
group1
A+B grade sperm count after treatment=0
Other: semen pretreatment
semen pretreatment

group2
0<A+B grade sperm count after treatment≤10^6
Other: semen pretreatment
semen pretreatment

group3
10^6<A+B grade sperm count after treatment<2*10^6
Other: semen pretreatment
semen pretreatment

group4
A+B grade sperm count after treatment≥2*10^6
Other: semen pretreatment
semen pretreatment




Primary Outcome Measures :
  1. high quality embryo rate for ICSI [ Time Frame: two years ]
    rate of embryo grade above 6CI on the third day after fertilization


Secondary Outcome Measures :
  1. fertilization rate of ICSI [ Time Frame: two years ]
    number of fertilized oocytes/ number of metaphase II oocytes

  2. normal fertilization rate of ICSI [ Time Frame: two years ]
    number of 2PN fertilized oocytes/ number of metaphase II oocytes



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infertile couples take ART treament due to poor male semen quality.
Criteria

Inclusion Criteria:

  • infertility female and sterility male for reproductive treatment

Exclusion Criteria:

  • chromosomal abnormalities
  • none retrieval oocyte
  • none oocyte for ICSI
  • Recurrent abortion
  • female age≥37 years
  • Assisted hatching
  • abnormal oocyte zona pellucida
  • In Vitro Maturation
  • AZF microdeletion

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): NCT03594201


Locations
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China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya
Investigators
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Principal Investigator: Liang Hu, MD,PHD Reproductive & Genetic Hospital of CITIC-Xiangya

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Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT03594201     History of Changes
Other Study ID Numbers: KYXM-201803
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Reproductive & Genetic Hospital of CITIC-Xiangya:
ICSI, progressive sperm count, embryo

Additional relevant MeSH terms:
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Infertility
Oligospermia
Genital Diseases, Male
Genital Diseases, Female
Infertility, Male