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OpenTrials
Completed

NCT Number: NCT03594201

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semen pretreatment

Other

semen pretreatment

Primary outcomes

  1. high quality embryo rate for ICSI

    Time frame: two years

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

Secondary outcomes

  1. fertilization rate of ICSI

    Time frame: two years

    number of fertilized oocytes/ number of metaphase II oocytes

  2. normal fertilization rate of ICSI

    Time frame: two years

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

Sponsors and collaborators

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 20, 2018
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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