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Completed

NCT Number: NCT06231589

PGT-A Evaluates Advanced Sperm Selection in Embryos From High Teratozoospermia Males

In this study of 264 couples, sperm selection techniques in males with high teratozoospermia index and sperm DNA fragmentation significantly increased fertilization, blastocyst development rates, and maintained comparable embryo euploidy rates through preimplantation genetic testing, suggesting the efficiency of these techniques in improving assisted reproductive outcomes.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

About this study

Couples seeking infertility treatment are becoming more frequent. Paternal factor shows one of the infertility causes which may have a negative impact on reproductive outcomes. Intracytoplasmic sperm injection (ICSI) is thought to be the most effective way to treat infertility. Sperm morphology evaluation is a reliable predictor of male fertility while teratozoospermia index (TZI) is a unique expression of sperm morphological assessment. A higher rate of abnormal sperm morphology tends to have higher sperm chromosomal abnormality rates. The choice of high-quality sperm through sperm selection techniques is expected to improve ICSI outcomes. In this study, a total number of 264 couples were included and divided into 3 groups: (1) Males have normal TZI (Control group: 111 males have TZI <1.6), (2) Males with high TZI and no sperm selection techniques are performed (NO-SS group: 63 males have TZI >1.8), and (3) Males with high TZI and sperm selection techniques are performed (SS-group: 90 males have TZI >1.8). The TZI was significantly (P<0.000) higher in the NO-SS and SS-group as compared to the control group. The percentage of sperm DNA fragmentation SDF in the males of the SS group was significantly higher than the controls and NO-SS group (P=0.000). The fertilization (P=0. 039) and blastocyst development rates (P= 0. 041) are significantly higher in the SS group as compared to the NO-SS group in females aged <35. A total of 1072 embryos were tested for preimplantation genetic testing for aneuploidy using NGS, although higher SDF in the males of the SS group, the embryo euploidy rates show that there is no significant difference between the SS group (56.35±3.46%) as compared to the control group (54.54±3.24%) and the NO-SS group (57.45±4.57%). In general, we found that sperm selection techniques are efficient techniques in increasing fertilization, blastocyst development rates, and euploidy rate in males with high teratozoospermia index and sperm DNA fragmentation combined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males diagnosed with normal and high teratozoospermia index.
  • Males with Mild to moderate OTA (oligoteratoasthenozoospermia).
  • Males aged 18-60 years.
  • Female aged 18-40 years.
  • Case must have PGT-A for all of her blastocysts.
  • 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 ICSI.

Exclusion criteria

  • Leukocytospermia.
  • Presence of varicocele.
  • Known genetic abnormality.
  • Use of sperm or oocyte donors.
  • 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

Sperm Selection

Device

Sperm selection using physiological intracytoplasmic sperm injection (PICSI dish) or magnetic-activated cell sorting (MACS) for selecting sperm with high-quality, better morphology and lower DNA fragmentation.

Primary outcomes

  1. Fertilization rate

    Time frame: 1 day

    Defined as the proportion of fertilizaed oocytes

  2. Blastocyst development rate

    Time frame: 5-6 days

    Defined as the proportion of blastocysts formed on day 5 or 6

  3. Euploidy rate

    Time frame: 15 days post ICSI

    Defined as the proportion of euploid blastocysts

  4. Aneuploidy rate

    Time frame: 15 days post ICSI

    Defined as the proportion of aneuploid blastocysts

Secondary outcomes

  1. Blastocyst quality rate

    Time frame: 5-6 days

    Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor

  2. Low mosaic rate

    Time frame: 15 days post ICSI

    Defined as the proportion of low mosaic blastocysts

  3. High mosaic rate

    Time frame: 15 days post ICSI

    Defined as the proportion of high mosaic blastocysts

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Official study title

Next Generation Sequencing of Embryos for Testing the Efficacy of Advanced Sperm Selection Techniques in Males With High Teratozoospermia Index

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2024
Registry last updated
Jan 30, 2024

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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