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

2026年6月29日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Abu Dhabi、阿拉伯联合酋长国
        • 招聘中
        • Fakih IVF
        • 接触:
        • 接触:
        • 首席研究员:
          • Michael Fakih, MD
        • 首席研究员:
          • Dr. Lamiya Mohiyiddeen, MD FRCOG
      • Abu Dhabi、阿拉伯联合酋长国
        • 主动,不招人
        • Khalifa University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Biochemical pregnancy
大体时间: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
大体时间: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
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Live birth or miscarriage
大体时间:From enrollment to delivery or miscarriage.
Live birth rates/ Miscarriage rates
From enrollment to delivery or miscarriage.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michael Fakih, MD、Fakih IVF Abu Dhabi
  • 首席研究员:Junaid Kashir, PhD、Khalifa University
  • 首席研究员:Dr. Lamiya Mohiyiddeen, MD、Fakih IVF Abu Dhabi

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • FAKIHIVF-001
  • DOH/ADHRTC/2024/2075 (其他标识符:Department of Health Abu Dhabi)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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