About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Male partners in couples suffering from infertility and seeking IVF treatment at the FAKIH IVF clinics in the UAE.
Trial design
Cohort
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionThis is a cohort observational study and there will be no intervention of any type.
Treatment groups
Trial outcomes
Primary outcomes
Biochemical pregnancy
Blood tested positive/ negative for pregnancy
Clinical Pregnancy result
Confirmation of presence or absence of a gestational sac and fetal heartbeat using ultrasound detection.
PLC Zeta measurement
Measurement of PLC Zeta by Immunofluorescence and Western Blotting
Secondary outcomes
Live birth or miscarriage
Live birth rates/ Miscarriage rates
Sponsors and contacts
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Fakih IVF Fertility Center
Lead sponsor
Khalifa University for Science and Technology
Collaborator