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Completed

NCT Number: NCT04482517

Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.

Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ganin Fertility Center

Cairo, Maadi, 1728, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female age was ≤37 years
  • Female should has 5≥ metaphase II oocytes
  • Males having abnormal SDF levels ≥ 20.3% by TUNEL assay
  • Abstinence from 1 to 2 days
  • Males having at least 1 million total motile progressive count

Exclusion criteria

  • 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

Density Gradient Centrifugation

Other

Semen processing is done by double layer density gradient method.

Other names: DGC

Physiological ICSI

Other

Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head

Other names: PICSI

Magnetic activated cell sorting

Other

Sperm selection by using Annexin V micro-beads and separation columns

Other names: MACS

Testicular sperm

Other

Using testicular sperm retrieved by TESA or TESE

Other names: Testi

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 14 days following embryo transfer

    Defined as clinical pregnancy per transfer

  2. 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.

  3. 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. Cleavage rate

    Time frame: 3 days

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

  2. 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. High quality blastocyst 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. Miscarriage rate

    Time frame: 20 weeks of gestation

    Defined as the proportion of miscarried cases

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Official study title

Reproductive Outcomes of Different Sperm Selection Techniques; Density Gradient Centrifugation, Testicular Sperm, PICSI, and MACS for ICSI Patients With Abnormal Sperm DNA Fragmentation

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2020
Registry last updated
Jul 22, 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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