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

Completed

• Conditions: Sperm Count, Low; Reproductive Sterility
• Interventions: Other: semen pretreatment

• Registration Number: NCT03594201
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-03
• Status Verified: 2018-07
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-20
• Last Update Submitted: 2019-05-19
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12215

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
high quality embryo rate for ICSI	two years	rate of embryo grade above 6CI on the third day after fertilization

Secondary Outcome Measures

Name	Time	Method
fertilization rate of ICSI	two years	number of fertilized oocytes/ number of metaphase II oocytes
normal fertilization rate of ICSI	two years	number of 2PN fertilized oocytes/ number of metaphase II oocytes

Trial Locations

Locations (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA; 🇨🇳 Changsha, Hunan, China