A Retrospective Study on the Effect of Male Progressive S... | NCT03594201

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

NCT03594201

Sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Status

Completed

Last Update Posted

May 21, 2019Actual

Enrollment

12,215Actual

Phase

Not provided

Conditions

Sperm Count, Low
Reproductive Sterility

Interventions

semen pretreatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jan 3, 2018Actual

First Submitted Date

Jul 11, 2018

First Submission Date that Met QC Criteria

Jul 11, 2018

First Posted Date

Jul 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2019

Last Update Posted Date

May 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,215Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
group1	A+B grade sperm count after treatment=0	Other: semen pretreatment
group2	0\	Other: semen pretreatment
group3	10^6\	Other: semen pretreatment
group4	A+B grade sperm count after treatment≥2*10^6	Other: semen pretreatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semen pretreatment	Other	semen pretreatment	group1 group2 group3 group4

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liang Hu, MD,PHD	Reproductive & Genetic Hospital of CITIC-Xiangya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive & Genetic Hospital of CITIC-XIANGYA		Changsha	Hunan	410008	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009845	Oligospermia
D007246	Infertility

Ancestor Terms

ID	Term
D007248	Infertility, Male
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided