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Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters

NCT07684339 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-07-06

No results posted yet for this study

Summary

With declining fertility rates Worldwide, Assisted Reproductive Technology is seen as a viable solution for infertility, however, individual success rates following ART remain relatively low, rarely exceeding \~50%. The European Society for Human Reproduction and Embryology (ESHRE) indicates pregnancy rates per embryo transfer remain below 50%. Additionally, male infertility is regarded as a leading contributor to global infertility with approximately a third of cases attributed to genetic causes while half of the cases remain unexplained.

In this observational study we investigate the correlation between phospholipase C Zeta (PLCζ ) measurements and semen parameters. PLCζ is a sperm-specific protein which is introduced into a mature egg (oocyte) following gamete fusion and upon introduction, PLCζ is believed to initiate a series of characteristic calcium ion oscillations which lead to oocyte activation and persist beyond the completion of meiosis.

Mounting evidence implicates defects in PLCζ in cases of male factor infertility where intracytoplasmic sperm injection (ICSI; whereby a single sperm is injected into the oocyte) is unsuccessful. Furthermore, defects in PLCζ are also increasingly implicated in cases of male sub-fertility, which affects a much larger proportion of the global population. Numerous studies now indicate that PLCζ not only holds significant value as a therapeutic to rescue cases of ICSI failure, but also as a prognostic diagnostic test of male fertility. Indeed, the reduction or absence of normal PLCζ within sperm has been linked to cases of male factor infertility in humans, either due to inactivation through mutation, due to abrogation of protein levels in sperm as a result of mutation in the PLCζ promoter, or mutations within coding exonic regions of the PLCζ gene. Such data indicate both therapeutic, and diagnostic applications for PLCζ within the fertility clinic. This study seeks to determine the effect of abnormal PLCζ on semen parameters and correlate that with downstream events including clinical pregnancy and live birth rates.

Conditions

  • Male Infertility
  • Male Subfertility

Interventions

OTHER

No Intervention: Observational Cohort

This is a cohort observational study and there will be no intervention of any type.

Sponsors & Collaborators

  • Khalifa University for Science and Technology

    collaborator OTHER

  • Fakih IVF Fertility Center

    lead OTHER

Principal Investigators

  • Junaid Kashir, PhD · Khalifa University

  • Dr. Lamiya Mohiyiddeen, MD · Fakih IVF Abu Dhabi

  • Michael Fakih, MD · Fakih IVF Abu Dhabi

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-01
Completion
2027-08-31

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684339 on ClinicalTrials.gov