Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters

NCT07684339 | Recruiting DMC

• 2 other identifiers: FAKIHIVF-001DOH/ADHRTC/2024/2075
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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%. 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.

Conditions

Male Infertility; Male Subfertility

Keywords

PLCζ; phospholipase C Zeta; Male Infertility

Outcome Measures

Primary Outcomes (3)

• Biochemical pregnancy

  Blood tested positive/ negative for pregnancy

  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.

  From enrollment to delivery (live birth or miscarriage)

• PLC Zeta measurement

  Measurement of PLC Zeta by Immunofluorescence and Western Blotting

  From enrollment to submission of sperm (1 day)

Secondary Outcomes (1)

• Live birth or miscarriage

  From enrollment to delivery or miscarriage.

Study Arms (1)

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.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

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

IVF-couples

Eligibility Criteria

• Gender Eligibility Details: Biological Male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fakih IVF Fertility Center: lead
• Khalifa University for Science and Technology: collaborator

Study Sites (2)

Fakih IVF

Abu Dhabi, United Arab Emirates

RECRUITING

Khalifa University

Abu Dhabi, United Arab Emirates

ACTIVE NOT RECRUITING

Related Publications (34)

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MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Junaid Kashir, PhD

  Khalifa University

  PRINCIPAL INVESTIGATOR

• Dr. Lamiya Mohiyiddeen, MD

  Fakih IVF Abu Dhabi

  PRINCIPAL INVESTIGATOR

• Michael Fakih, MD

  Fakih IVF Abu Dhabi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Lamiya Mohiyiddeen, MD, FRCOG

CONTACT

+971543676002; lamiya.mohiyiddeen@fakihivf.com

Fatma Bathawab, PhD

CONTACT

+971585707393; fatma.bathawab@fakihivf.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, Research Ethics Committee Chair

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (2)