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

NCT ID: NCT03594201

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-01-03

Brief Summary

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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

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Conditions

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Sperm Count, Low Reproductive Sterility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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group1

A+B grade sperm count after treatment=0

semen pretreatment

Intervention Type OTHER

semen pretreatment

group2

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

semen pretreatment

Intervention Type OTHER

semen pretreatment

group3

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

semen pretreatment

Intervention Type OTHER

semen pretreatment

group4

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

semen pretreatment

Intervention Type OTHER

semen pretreatment

Interventions

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semen pretreatment

semen pretreatment

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liang Hu, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Reproductive & Genetic Hospital of CITIC-Xiangya

Locations

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Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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KYXM-201803

Identifier Type: -

Identifier Source: org_study_id

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