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Completed

NCT Number: NCT03398317

Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI

On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ganin Fertility Center

Cairo, Egypt

About this study

Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester.

Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates.

A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation.

In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of patients

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males diagnosed of abnormal DNA fragmentation index ( > 19%).
  • Males with mild to moderate OTA (oligoteratoasthenozoospermia).
  • Male aged 18-60 years.
  • Female aged 18-40 years.
  • Normo responder ( > 5 mature oocytes)
  • Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of oocyte retrieval

Exclusion criteria

Males with normalDNA fragmentation index (<19%)at the initial assessment.

  • Leukocytospermia
  • Presence of varicocele.
  • Known genetic abnormality
  • Use of sperm donation or cryopreserved sperm
  • Use of Oocyte donation
  • Use of gestational carrier
  • Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
  • Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Treatment and study plan

PICSI

Other

sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index

MACS

Other

sperm selection using MACS for selecting sperm with lower DNA fragmentation index

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 20 weeks of gestation

    Defined as the proportion of pregnancies that completed more than 20 weeks of gestation

Secondary outcomes

  1. Comparison of cleavage rate

    Time frame: 3 days

    Defined as the proportion of cleaved embryos on day 3 over the injected oocytes

  2. Comparison of Blastulation rate

    Time frame: 5-6 days

    Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3

  3. Comparison of Blastocyst quality rate

    Time frame: 5-6 days

    Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or bad in terms of percentage of the total formed blastocysts

  4. Comparison of Pregnancy rate

    Time frame: 14 days following embryo transfer

    Defined as clinical pregnancy per transfer

  5. Comparison of implantation rate

    Time frame: 6- 8 weeks following embryo transfer

    Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Collaborators

  • The Cleveland Clinic
  • University of the Western Cape

Registry information

Official study title

PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Jul 21, 2020

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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