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

NCT06476379 | Completed

• 1 other identifier: GFC-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Male Infertility

Keywords

ICSI; Male infertility; PGT-A; TESE

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Fertilization rate

  1 day

• Cleavage rate

  3 days

• Blastocyst development rate

  5-6 days

Study Arms (2)

Ejaculate

ACTIVE COMPARATOR

Patients within this arm will undergo ICSI utilizing ejaculated sperm.

Other: Ejaculate

Testicular

ACTIVE COMPARATOR

Patients within this arm will undergo ICSI utilizing testicular sperm.

Procedure: Testicular sperm extraction (TESE)

Interventions

Testicular sperm extraction (TESE) PROCEDURE

Surgical procedure used to retrieve sperm directly from the testicles of men who have low sperm production or no sperm in their ejaculate

Testicular

Ejaculate OTHER

Ejaculate processing for ICSI

Ejaculate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ganin Fertility Center: lead

Study Sites (1)

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

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

Study Officials

• Eman Hasanen

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Hosam Zaki, FRCOG

  Ganin Fertility Center

  STUDY CHAIR

• Refaat Gabre, PhD

  Faculty of Science, Cairo University

  STUDY DIRECTOR

• Mohamed Abbas

  Cairo University

  STUDY CHAIR

• Nahla Osama, Phd

  Faculty of Science, Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: June 25, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 15, 2025

Record last verified: 2024-06

Locations

EG (1)