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

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.

Study Overview

• Status: Completed
• Conditions: Sperm Count, Low; Reproductive Sterility
• Intervention / Treatment: Other: semen pretreatment

• Study Type: Observational
• Enrollment (Actual): 12215

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Reproductive & Genetic Hospital of Citic-Xiangya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infertile couples take ART treament due to poor male semen quality.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high quality embryo rate for ICSI	rate of embryo grade above 6CI on the third day after fertilization	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fertilization rate of ICSI	number of fertilized oocytes/ number of metaphase II oocytes	two years
normal fertilization rate of ICSI	number of 2PN fertilized oocytes/ number of metaphase II oocytes	two years

Collaborators and Investigators

• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): January 3, 2018

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (ACTUAL): July 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 19, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: ICSI, progressive sperm count, embryo
• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Oligospermia
• Other Study ID Numbers: KYXM-201803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No