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

NCT03594201 | Completed

• 1 other identifier: KYXM-201803
• Study Type: observational
• Target: 12,215
• Locations: 1 country
• Sites: 1

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.

Conditions

Sperm Count, Low; Reproductive Sterility

Keywords

ICSI, progressive sperm count, embryo

Outcome Measures

Primary Outcomes (1)

• high quality embryo rate for ICSI

  rate of embryo grade above 6CI on the third day after fertilization

  two years

Secondary Outcomes (2)

• fertilization rate of ICSI

  two years

• normal fertilization rate of ICSI

  two years

Study Arms (4)

group1

A+B grade sperm count after treatment=0

Other: semen pretreatment

group2

0\<A+B grade sperm count after treatment≤10\^6

Other: semen pretreatment

group3

10\^6\<A+B grade sperm count after treatment\<2\*10\^6

Other: semen pretreatment

group4

A+B grade sperm count after treatment≥2\*10\^6

Other: semen pretreatment

Interventions

semen pretreatment OTHER

semen pretreatment

group1; group2; group3; group4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• infertility female and sterility male for reproductive treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Oligospermia; Infertility

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Liang Hu, MD,PHD

  Reproductive & Genetic Hospital of CITIC-Xiangya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 20, 2018
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: January 3, 2018
• Last Updated: May 21, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)