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

Ganin Fertility Center

Status: Completed

Conditions: Male Infertility

Treatments: Other: Ejaculate; Procedure: Testicular sperm extraction (TESE)

Study type: Interventional

Funder types: Other

Identifiers

NCT06476379

GFC-009

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ejaculate

Active Comparator group

Description:

Patients within this arm will undergo ICSI utilizing ejaculated sperm.

Treatment:

Other: Ejaculate

Testicular

Active Comparator group

Description:

Patients within this arm will undergo ICSI utilizing testicular sperm.

Treatment:

Procedure: Testicular sperm extraction (TESE)