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

29. Juni 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

      • Abu Dhabi, Vereinigte Arabische Emirate
        • Rekrutierung
        • Fakih IVF
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Michael Fakih, MD
        • Hauptermittler:
          • Dr. Lamiya Mohiyiddeen, MD FRCOG
      • Abu Dhabi, Vereinigte Arabische Emirate
        • Aktiv, nicht rekrutierend
        • Khalifa University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Biochemical pregnancy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Live birth or miscarriage
Zeitfenster: From enrollment to delivery or miscarriage.
Live birth rates/ Miscarriage rates
From enrollment to delivery or miscarriage.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juli 2027

Studienabschluss (Geschätzt)

1. August 2027

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juni 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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