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

R

Reproductive & Genetic Hospital of CITIC-Xiangya

Status

Completed

Conditions

Sperm Count, Low
Reproductive Sterility

Treatments

Other: semen pretreatment

Study type

Observational

Funder types

Other

Identifiers

NCT03594201
KYXM-201803

Details and patient eligibility

About

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.

Enrollment

12,215 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

12,215 participants in 4 patient groups

group1
Description:
A+B grade sperm count after treatment=0
Treatment:
Other: semen pretreatment
group2
Description:
0\<A+B grade sperm count after treatment≤10\^6
Treatment:
Other: semen pretreatment
group3
Description:
10\^6\<A+B grade sperm count after treatment\<2\*10\^6
Treatment:
Other: semen pretreatment
group4
Description:
A+B grade sperm count after treatment≥2\*10\^6
Treatment:
Other: semen pretreatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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