Can the Origin of Sperm Affect Embryo Ploidy in Patients With Severe Male Factor Infertility?

Can the Origin of Sperm - Ejaculated or Testicular- Affect Embryo Ploidy in Patients With Severe Male Factor Infertility?

There is evidence indicating that sperm plays a role in determining blastocyst ploidy status. In our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (PGT-A) and the subsequent clinical outcomes following transfers of euploid embryos. This comparison will be conducted between cases where ejaculated sperm and cases where testicular sperm were used for intracytoplasmic sperm injection (ICSI), specifically focusing on severe male factor infertility patients.

Study Overview

• Status: Completed
• Conditions: Male Infertility
• Intervention / Treatment: Other: Ejaculate; Procedure: Testicular sperm extraction (TESE)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Maadi
    • Cairo, Maadi, Egypt, 11728
      • Ganin Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cases planned to have ICSI PGT-A cycles
• Males diagnosed as severe male factor infertility
• Normo responder female partners

Exclusion Criteria:

• Leukocytospermia
• Presence of varicocele.
• Known genetic abnormality
• Use of sperm or oocyte donors
• Use of gestational carrier
• Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
• Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ejaculate; Patients within this arm will undergo ICSI utilizing ejaculated sperm.	Other: Ejaculate; Ejaculate processing for ICSI
Active Comparator: Testicular; Patients within this arm will undergo ICSI utilizing testicular sperm.	Procedure: Testicular sperm extraction (TESE); Surgical procedure used to retrieve sperm directly from the testicles of men who have low sperm production or no sperm in their ejaculate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Euploidy rate	Defined as the proportion of euploid blastocysts	15 days post ICSI
Aneuploidy rate	Defined as the proportion of aneuploid blastocysts	15 days post ICSI
Low mosaic rate	Defined as the proportion of low mosaic blastocysts	Time Frame: 15 days post ICSI
High mosaic rate	Defined as the proportion of high mosaic blastocysts	Time Frame: 15 days post ICSI
Implantation rate	defined as the percentage of successfully implanted embryos	6-9 weeks post-embryo transfer
Ongoing pregnancy rate	defined as a positive heartbeat on ultrasound beyond 12 weeks of gestation	12 weeks of gestation
Miscarriage rate	defined as pregnancy loss following confirmation of clinical pregnancy	after 6 weeks of gestation
Clinical pregnancy rate	defined as the presence of a fetal heartbeat or gestational sac 6-9 weeks post-embryo transfer	6-9 weeks post-embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization rate	Defined as the proportion of fertilizaed oocytes	1 day
Cleavage rate	Defined as the proportion of cleaved embryos on day 3	3 days
Blastocyst development rate	Defined as the proportion of blastocysts formed on day 5 or 6	5-6 days

Collaborators and Investigators

• Sponsor: Ganin Fertility Center
• Investigators: Principal Investigator: Eman Hasanen, Ganin Fertility Center; Study Chair: Mohamed Abbas, Cairo university; Study Chair: Hosam Zaki, FRCOG, Ganin Fertility Center; Study Director: Refaat Gabre, PhD, Faculty of Science, Cairo University; Study Chair: Nahla Osama, Phd, Faculty of Science, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: PGT-A; Male infertility; ICSI; TESE
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility; Infertility, Male
• Other Study ID Numbers: GFC-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No