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

Reproductive Sterility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594201
• Other study ID #: KYXM-201803
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: January 3, 2018

Study information

• Verified date: July 2018
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12215
• Est. completion date: January 3, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Oligospermia
• Reproductive Sterility
• Sperm Count, Low

Intervention

Other:
• semen pretreatment
semen pretreatment

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high quality embryo rate for ICSI	rate of embryo grade above 6CI on the third day after fertilization	two years
Secondary	fertilization rate of ICSI	number of fertilized oocytes/ number of metaphase II oocytes	two years
Secondary	normal fertilization rate of ICSI	number of 2PN fertilized oocytes/ number of metaphase II oocytes	two years