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OpenTrials
Completed

NCT Number: NCT04496232

Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial

Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.

Completed

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ganin Fertility Center

Cairo, Cairo Governorate, 11728, Egypt

About this study

Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male partner with abnormal sperm DNA fragmentation index (>20%) by TUNEL assay
  • Male partner with at least 1 million progressive motile count
  • Male aged 18-50 years
  • Male with adjusted sexual abstinence days (1-2 days)
  • Female aged 18-37 years
  • Normo-responder females (at least 5 mature oocytes)

Exclusion criteria

  • Leukocytospermia
  • Varicocele
  • Known genetic abnormality
  • Use of oocyte or sperm donors
  • Use of a gestational carrier
  • Presence of any endometrial factors that can affect embryo implantation
  • Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Treatment and study plan

PICSI

Device

Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate

Second ejaculate

Other

Semen processing by density gradient centrifugation for the second ejaculate

Primary outcomes

  1. Fertilization rate

    Time frame: 16-19 hours

    Defined as the proportion of fertilized oocytes over the injected oocytes.

  2. Cleavage rate

    Time frame: 3 days

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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2020
Registry last updated
Aug 9, 2022

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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