Male InfertilityPLCZetaNCT07684339
Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters
An observational study of Male Infertility and Male Subfertility, run by Fakih IVF Fertility Center at 2 sites in United Arab Emirates.
Trial summary
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%. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Male Infertility, Male Subfertility
- How many people
- 200 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 1 Jul 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male partners in couples suffering from infertility and seeking IVF treatment at the FAKIH IVF clinics in the UAE.
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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates2 sites, 1 recruiting
- Recruiting
Fakih IVF
Abu Dhabi
Dr. Lamiya Mohiyiddeen, MD, FRCOG, +971543676002, lamiya.mohiyiddeen@fakihivf.com
Fatma Bathawab, PhD, +971585707393, fatma.bathawab@fakihivf.com
- Active, not recruiting
Khalifa University
Abu Dhabi
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Male Infertility, Male Subfertility
- Being tested
- No Intervention: Observational Cohort
- Keywords
- PLCζ, phospholipase C Zeta, Male Infertility
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This is a cohort observational study and there will be no intervention of any type.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical pregnancy
Blood tested positive/ negative for pregnancy
Measured: From enrollment to clinical pregnancy result and delivery where applicable.
Clinical Pregnancy result
Confirmation of presence or absence of a gestational sac and fetal heartbeat using ultrasound detection.
Measured: From enrollment to delivery (live birth or miscarriage)
PLC Zeta measurement
Measurement of PLC Zeta by Immunofluorescence and Western Blotting
Measured: From enrollment to submission of sperm (1 day)
Secondary outcomes (1)
Live birth or miscarriage
Live birth rates/ Miscarriage rates
Measured: From enrollment to delivery or miscarriage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakih IVF Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- Khalifa University for Science and Technology
- Responsible party
- Principal investigator, Lamiya Mohiyiddeen, Fakih IVF Fertility Center
- Investigators
- Junaid Kashir, PhD, Principal investigator, Khalifa UniversityDr. Lamiya Mohiyiddeen, MD, Principal investigator, Fakih IVF Abu DhabiMichael Fakih, MD, Principal investigator, Fakih IVF Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684339
- Sponsor's protocol ID
- FAKIHIVF-001
- Other IDs
- DOH/ADHRTC/2024/2075
- Acronym
- PLCZeta
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization, 2010, Fifth Edition. ISBN: 978 92 4 154778 9.
Yamaguchi et al., Cell Calcium 2017;pii: S0143-4160(16)30191-9.
Janghorban-Laricheh E, Ghazavi-Khorasgani N, Tavalaee M, Zohrabi D, Abbasi H, Nasr-Esfahani MH. An association between sperm PLCzeta levels and varicocele? J Assist Reprod Genet. 2016 Dec;33(12):1649-1655. doi: 10.1007/s10815-016-0802-5. Epub 2016 Sep 9.
PubMed 27612872Kamali-Dolat Abadi M, Tavalaee M, Shahverdi A, Nasr-Esfahani MH. Evaluation of PLCzeta and PAWP Expression in Globozoospermic Individuals. Cell J. 2016 Fall;18(3):438-45. doi: 10.22074/cellj.2016.4572. Epub 2016 Aug 24.
PubMed 27602326Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3.
PubMed 20890283Miyazaki S, Ito M. Calcium signals for egg activation in mammals. J Pharmacol Sci. 2006;100(5):545-52. doi: 10.1254/jphs.cpj06003x.
PubMed 16799264Fulton BP, Whittingham DG. Activation of mammalian oocytes by intracellular injection of calcium. Nature. 1978 May 11;273(5658):149-51. doi: 10.1038/273149a0. No abstract available.
PubMed 565475Ducibella T, Schultz RM, Ozil JP. Role of calcium signals in early development. Semin Cell Dev Biol. 2006 Apr;17(2):324-32. doi: 10.1016/j.semcdb.2006.02.010. Epub 2006 Mar 2.
PubMed 16580237Ducibella T, Huneau D, Angelichio E, Xu Z, Schultz RM, Kopf GS, Fissore R, Madoux S, Ozil JP. Egg-to-embryo transition is driven by differential responses to Ca(2+) oscillation number. Dev Biol. 2002 Oct 15;250(2):280-91.
PubMed 12376103Escoffier J, Lee HC, Yassine S, Zouari R, Martinez G, Karaouzene T, Coutton C, Kherraf ZE, Halouani L, Triki C, Nef S, Thierry-Mieg N, Savinov SN, Fissore R, Ray PF, Arnoult C. Homozygous mutation of PLCZ1 leads to defective human oocyte activation and infertility that is not rescued by the WW-binding protein PAWP. Hum Mol Genet. 2016 Mar 1;25(5):878-91. doi: 10.1093/hmg/ddv617. Epub 2015 Dec 31.
PubMed 26721930Ferrer-Vaquer A, Barragan M, Freour T, Vernaeve V, Vassena R. PLCzeta sequence, protein levels, and distribution in human sperm do not correlate with semen characteristics and fertilization rates after ICSI. J Assist Reprod Genet. 2016 Jun;33(6):747-56. doi: 10.1007/s10815-016-0718-0. Epub 2016 May 2.
PubMed 27138933Kashir J, Konstantinidis M, Jones C, Heindryckx B, De Sutter P, Parrington J, Wells D, Coward K. Characterization of two heterozygous mutations of the oocyte activation factor phospholipase C zeta (PLCzeta) from an infertile man by use of minisequencing of individual sperm and expression in somatic cells. Fertil Steril. 2012 Aug;98(2):423-31. doi: 10.1016/j.fertnstert.2012.05.002. Epub 2012 May 24.
PubMed 22633260Kashir J, Konstantinidis M, Jones C, Lemmon B, Lee HC, Hamer R, Heindryckx B, Deane CM, De Sutter P, Fissore RA, Parrington J, Wells D, Coward K. A maternally inherited autosomal point mutation in human phospholipase C zeta (PLCzeta) leads to male infertility. Hum Reprod. 2012 Jan;27(1):222-31. doi: 10.1093/humrep/der384. Epub 2011 Nov 16.
PubMed 22095789Kashir J, Buntwal L, Nomikos M, Calver BL, Stamatiadis P, Ashley P, Vassilakopoulou V, Sanders D, Knaggs P, Livaniou E, Bunkheila A, Swann K, Lai FA. Antigen unmasking enhances visualization efficacy of the oocyte activation factor, phospholipase C zeta, in mammalian sperm. Mol Hum Reprod. 2017 Jan;23(1):54-67. doi: 10.1093/molehr/gaw073. Epub 2016 Dec 8.
PubMed 27932551Theodoridou M, Nomikos M, Parthimos D, Gonzalez-Garcia JR, Elgmati K, Calver BL, Sideratou Z, Nounesis G, Swann K, Lai FA. Chimeras of sperm PLCzeta reveal disparate protein domain functions in the generation of intracellular Ca2+ oscillations in mammalian eggs at fertilization. Mol Hum Reprod. 2013 Dec;19(12):852-64. doi: 10.1093/molehr/gat070. Epub 2013 Oct 23.
PubMed 24152875
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Correlation Between Phospholipase C Zeta (PLCZeta) Measurements and Semen Parameters
- ClinicalTrials.gov ID
- NCT07684339
- Acronym / sponsor ID
- PLCZeta / FAKIHIVF-001
- Conditions
- Male Infertility, Male Subfertility
- Keywords
- PLCζ, phospholipase C Zeta, Male Infertility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fakih IVF Fertility CenterUniversity, hospital or other
- Collaborators
- Khalifa University for Science and Technology
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF-couples | – | Other: No Intervention: Observational CohortMale 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male partners in couples suffering from infertility and seeking IVF treatment at the FAKIH IVF clinics in the UAE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThis is a cohort observational study and there will be no intervention of any type. | Other | IVF-couples |
Primary outcome
Biochemical pregnancy
Time frame: From enrollment to clinical pregnancy result and delivery where applicable.
Blood tested positive/ negative for pregnancy
Clinical Pregnancy result
Time frame: From enrollment to delivery (live birth or miscarriage)
Confirmation of presence or absence of a gestational sac and fetal heartbeat using ultrasound detection.
PLC Zeta measurement
Time frame: From enrollment to submission of sperm (1 day)
Measurement of PLC Zeta by Immunofluorescence and Western Blotting
1 secondary outcome
Live birth or miscarriage
Time frame: From enrollment to delivery or miscarriage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- BackgroundWorld Health Organization, 2010, Fifth Edition. ISBN: 978 92 4 154778 9.
- BackgroundYamaguchi et al., Cell Calcium 2017;pii: S0143-4160(16)30191-9.
- Background: PubMed 27612872Janghorban-Laricheh E, Ghazavi-Khorasgani N, Tavalaee M, Zohrabi D, Abbasi H, Nasr-Esfahani MH. An association between sperm PLCzeta levels and varicocele? J Assist Reprod Genet. 2016 Dec;33(12):1649-1655. doi: 10.1007/s10815-016-0802-5. Epub 2016 Sep 9.
- Background: PubMed 27602326Kamali-Dolat Abadi M, Tavalaee M, Shahverdi A, Nasr-Esfahani MH. Evaluation of PLCzeta and PAWP Expression in Globozoospermic Individuals. Cell J. 2016 Fall;18(3):438-45. doi: 10.22074/cellj.2016.4572. Epub 2016 Aug 24.
- Background: PubMed 20890283Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3.
- Background: PubMed 16799264Miyazaki S, Ito M. Calcium signals for egg activation in mammals. J Pharmacol Sci. 2006;100(5):545-52. doi: 10.1254/jphs.cpj06003x.
- Background: PubMed 565475Fulton BP, Whittingham DG. Activation of mammalian oocytes by intracellular injection of calcium. Nature. 1978 May 11;273(5658):149-51. doi: 10.1038/273149a0. No abstract available.
- Background: PubMed 16580237Ducibella T, Schultz RM, Ozil JP. Role of calcium signals in early development. Semin Cell Dev Biol. 2006 Apr;17(2):324-32. doi: 10.1016/j.semcdb.2006.02.010. Epub 2006 Mar 2.
- Background: PubMed 12376103Ducibella T, Huneau D, Angelichio E, Xu Z, Schultz RM, Kopf GS, Fissore R, Madoux S, Ozil JP. Egg-to-embryo transition is driven by differential responses to Ca(2+) oscillation number. Dev Biol. 2002 Oct 15;250(2):280-91.
- Background: PubMed 26721930Escoffier J, Lee HC, Yassine S, Zouari R, Martinez G, Karaouzene T, Coutton C, Kherraf ZE, Halouani L, Triki C, Nef S, Thierry-Mieg N, Savinov SN, Fissore R, Ray PF, Arnoult C. Homozygous mutation of PLCZ1 leads to defective human oocyte activation and infertility that is not rescued by the WW-binding protein PAWP. Hum Mol Genet. 2016 Mar 1;25(5):878-91. doi: 10.1093/hmg/ddv617. Epub 2015 Dec 31.
- Background: PubMed 27138933Ferrer-Vaquer A, Barragan M, Freour T, Vernaeve V, Vassena R. PLCzeta sequence, protein levels, and distribution in human sperm do not correlate with semen characteristics and fertilization rates after ICSI. J Assist Reprod Genet. 2016 Jun;33(6):747-56. doi: 10.1007/s10815-016-0718-0. Epub 2016 May 2.
- Background: PubMed 22633260Kashir J, Konstantinidis M, Jones C, Heindryckx B, De Sutter P, Parrington J, Wells D, Coward K. Characterization of two heterozygous mutations of the oocyte activation factor phospholipase C zeta (PLCzeta) from an infertile man by use of minisequencing of individual sperm and expression in somatic cells. Fertil Steril. 2012 Aug;98(2):423-31. doi: 10.1016/j.fertnstert.2012.05.002. Epub 2012 May 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junaid Kashir, PhD principal investigator
Khalifa University
Dr. Lamiya Mohiyiddeen, MD principal investigator
Fakih IVF Abu Dhabi
Michael Fakih, MD principal investigator
Fakih IVF Abu Dhabi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility and Male Subfertility, run by Fakih IVF Fertility Center at 2 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Lamiya Mohiyiddeen, MD, FRCOG (+971543676002, lamiya.mohiyiddeen@fakihivf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical pregnancy (time frame: From enrollment to clinical pregnancy result and delivery where applicable.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07684339, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.