NCT07684339 Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters
| NCT ID | NCT07684339 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fakih IVF Fertility Center |
| Condition | Male Infertility |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-08-01 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Couple inclusion criteria: * Presenting to the IVF clinic for IVF/ICSI treatment or routine semen analysis * Semen sample must have a total sperm count of ≥1 million sperm/ml * Availability of excess, leftover sperm after clinical treatment procedures * Couples must have experienced infertility for at least one year and be undergoing fertility treatment * Undergoing standard clinical treatment protocols (including embryo culture and, when applicable, PGTA) with routinely collected treatment outcome data * Sufficient ovarian reserve and/or meeting the clinic's standard criteria for fertility treatment Couple exclusion criteria: * Known genetic disorders affecting fertility * History of vasectomy or other irreversible sterilization procedures * Current use of medications known to affect sperm parameters (e.g., exogenous androgens, chemotherapeutic agents, or other drugs specifically impacting spermatogenesis) * Recent history of chemotherapy or radiation therapy * Female age \>38 years old * Known chromosomal abnormalities or genetic disorders that directly affect oocyte quality or embryo development * Presence of severe uterine or pelvic pathology (e.g., significant uterine anomalies, advanced endometriosis) * Documented ovarian failure or extremely diminished ovarian reserve as determined by AMH levels (AMH \>1 ng/mL, AFC ≥5) * Use of medications or undergoing treatments that could significantly alter oocyte quality or embryogenesis (outside standard ART protocols).
Contact & Investigator
Michael Fakih, MD
PRINCIPAL INVESTIGATOR
Fakih IVF Abu Dhabi
Frequently Asked Questions
Who can join the NCT07684339 clinical trial?
This trial is open to male participants only, studying Male Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07684339 currently recruiting?
Yes, NCT07684339 is actively recruiting participants. Contact the research team at lamiya.mohiyiddeen@fakihivf.com for enrollment information.
Where is the NCT07684339 trial being conducted?
This trial is being conducted at Abu Dhabi, United Arab Emirates, Abu Dhabi, United Arab Emirates.
Who is sponsoring the NCT07684339 clinical trial?
NCT07684339 is sponsored by Fakih IVF Fertility Center. The principal investigator is Michael Fakih, MD at Fakih IVF Abu Dhabi. The trial plans to enroll 200 participants.