Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorFakih IVF Fertility Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: IVF-couples1 intervention

Trial outcomes

Primary outcomes

1

Biochemical pregnancy

Blood tested positive/ negative for pregnancy

Time frame
From enrollment to clinical pregnancy result and delivery where applicable.
2

Clinical Pregnancy result

Confirmation of presence or absence of a gestational sac and fetal heartbeat using ultrasound detection.

Time frame
From enrollment to delivery (live birth or miscarriage)
3

PLC Zeta measurement

Measurement of PLC Zeta by Immunofluorescence and Western Blotting

Time frame
From enrollment to submission of sperm (1 day)

Secondary outcomes

1

Live birth or miscarriage

Live birth rates/ Miscarriage rates

Time frame
From enrollment to delivery or miscarriage.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fakih IVF Fertility Center

Lead sponsor

Khalifa University for Science and Technology

Collaborator