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

Sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya (Other)

Overall Status

Completed

CT.gov ID

NCT03594201

Collaborator

(none)

12,215

Enrollment

Location

24.1

Actual Duration (Months)

507.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sperm Count, Low Reproductive Sterility	Other: semen pretreatment

Study Design

Study Type:

Observational

Actual Enrollment :

12215 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Jan 3, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

high quality embryo rate for ICSI [two years]
rate of embryo grade above 6CI on the third day after fertilization

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan	China	410008

Sponsors and Collaborators

Reproductive & Genetic Hospital of CITIC-Xiangya

Investigators

Principal Investigator: Liang Hu, MD,PHD, Reproductive & Genetic Hospital of CITIC-Xiangya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reproductive & Genetic Hospital of CITIC-Xiangya

ClinicalTrials.gov Identifier:

NCT03594201

Other Study ID Numbers:

KYXM-201803

First Posted:

Jul 20, 2018

Last Update Posted:

May 21, 2019

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Reproductive & Genetic Hospital of CITIC-Xiangya

ICSI, progressive sperm count, embryo

Additional relevant MeSH terms:

Infertility

Oligospermia

Study Results

No Results Posted as of May 21, 2019