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CompletedNCT03594201Updated May 21, 2019

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

An observational study in Sperm Count, Low and Reproductive Sterility, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2019-05-21.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
12,215
Sex
All
01

Study 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.

02

Conditions studied

  • Sperm Count, Low
  • Reproductive Sterility

Keywords

  • ICSI, progressive sperm count, embryo
03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's enrollment of 12,215 is above the median of 300 across 17 observational studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • infertility female and sterility male for reproductive treatment

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
12,215 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othersemen pretreatment

    semen pretreatment

06

What researchers measure

Primary outcomes

  1. high quality embryo rate for ICSI

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

    Time frame: two years

Secondary outcomes

  1. fertilization rate of ICSI

    number of fertilized oocytes/ number of metaphase II oocytes

    Time frame: two years

  2. normal fertilization rate of ICSI

    number of 2PN fertilized oocytes/ number of metaphase II oocytes

    Time frame: two years

07

Study locations

1 site
  • Reproductive & Genetic Hospital of CITIC-XIANGYA
    Changsha, Hunan 410008, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Dec 2017, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2018
First posted
Jul 20, 2018
StartActual
Jan 1, 2016
Primary completionActual
Dec 31, 2017
CompletionActual
Jan 3, 2018
Last update
May 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03594201
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
Jul 20, 2018
Start date
Jan 1, 2016
Primary completion
Dec 31, 2017
Completion
Jan 3, 2018
Last update
May 21, 2019

Study contacts

Liang Hu, MD,PHD
principal investigator · Reproductive & Genetic Hospital of CITIC-Xiangya

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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