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Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters (PLCZeta)

29 juni 2026 bijgewerkt door: Lamiya Mohiyiddeen, Fakih IVF Fertility Center

Assessing the Correlation Between Phospholipase C Zeta (PLCZeta) Measurements and Semen Parameters

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.

Studie Overzicht

Gedetailleerde beschrijving

Despite advances in assisted reproductive technology (ART), significant gaps remain in understanding recurrent implantation failure and abortive embryogenesis. Male factor infertility is globally the leading cause of infertility, and is particularly prevalent in GCC countries, notably the UAE; where fertility rates have halved over the past decade, driven by cultural, lifestyle, and environmental shifts. Poor semen parameters (sperm count, motility, and morphology) account for 41% of infertility cases in the region.

The financial burden is substantial: a single ART cycle can exceed AED 30,000, with couples typically requiring 2-3 cycles (AED 60,000-100,000), translating to an estimated national expenditure of ~AED 0.5 billion annually in fertility treatments alone, excluding associated healthcare investigations.

A critical and underexplored mechanism underlying poor ART outcomes involves oocyte activation, initiated at fertilization by characteristic intracellular calcium (Ca²⁺) oscillations. These are triggered by phospholipase C zeta (PLCζ), a sperm-specific protein delivered into the oocyte upon gamete fusion. Ca²⁺ oscillation profiles directly govern cell cycle progression, embryo gene expression, and early developmental competence; deviations in amplitude or frequency compromise embryo quality. Notably, preimplantation mouse studies show that both insufficient and excessive PLCζ impair blastocyst development, with successful outcomes occurring within a ~4-fold effective dose range - mirroring the natural variation of PLCζ levels observed across fertile men.

Mounting clinical evidence links reduced or absent sperm PLCζ to fertilization failure following intracytoplasmic sperm injection (ICSI), as well as to broader male sub-fertility. PLCζ deficiencies may arise through point mutations, promoter alterations, or disrupted exonic regions, and correlate with known sperm defects including poor motility, globozoospermia, and elevated DNA fragmentation. Crucially, even when residual PLCζ is sufficient to trigger oocyte activation, it may be inadequate for full embryonic competence, a distinction with major clinical implications for sub-fertile men.

Despite this evidence, the direct relationship between sperm PLCζ parameters and downstream outcomes including embryonic efficacy, recurrent implantation failure, and ART success rates has not yet been systematically investigated. We propose that abnormalities in PLCζ-mediated Ca²⁺ oscillations represent a significant and underappreciated contributor to poor global ART outcomes. Establishing this link would position PLCζ as both a prognostic diagnostic marker of sperm health and a therapeutic agent, with the potential to improve outcomes across a broad spectrum of infertility presentations beyond complete fertilization failure.

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

      • Abu Dhabi, Verenigde Arabische Emiraten
        • Werving
        • Fakih IVF
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Michael Fakih, MD
        • Hoofdonderzoeker:
          • Dr. Lamiya Mohiyiddeen, MD FRCOG
      • Abu Dhabi, Verenigde Arabische Emiraten
        • Actief, niet wervend
        • Khalifa University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Male partners in couples suffering from infertility and seeking IVF treatment at the FAKIH IVF clinics in the UAE.

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
IVF-couples
Male partners in couples seeking fertility treatment via IVF and excluding any couples with factors known to negatively affect in spermatogenesis and embryogenesis. Couples must be experiencing infertility for 1 year or more before beginning IVF treatment.
This is a cohort observational study and there will be no intervention of any type.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Biochemical pregnancy
Tijdsspanne: From enrollment to clinical pregnancy result and delivery where applicable.
Blood tested positive/ negative for pregnancy
From enrollment to clinical pregnancy result and delivery where applicable.
Clinical Pregnancy result
Tijdsspanne: From enrollment to delivery (live birth or miscarriage)
Confirmation of presence or absence of a gestational sac and fetal heartbeat using ultrasound detection.
From enrollment to delivery (live birth or miscarriage)
PLC Zeta measurement
Tijdsspanne: From enrollment to submission of sperm (1 day)
Measurement of PLC Zeta by Immunofluorescence and Western Blotting
From enrollment to submission of sperm (1 day)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Live birth or miscarriage
Tijdsspanne: From enrollment to delivery or miscarriage.
Live birth rates/ Miscarriage rates
From enrollment to delivery or miscarriage.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Michael Fakih, MD, Fakih IVF Abu Dhabi
  • Hoofdonderzoeker: Junaid Kashir, PhD, Khalifa University
  • Hoofdonderzoeker: Dr. Lamiya Mohiyiddeen, MD, Fakih IVF Abu Dhabi

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

29 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juni 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

29 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • FAKIHIVF-001
  • DOH/ADHRTC/2024/2075 (Andere identificatie: Department of Health Abu Dhabi)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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