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

NCT ID: NCT06476379

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Male Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ejaculate

Patients within this arm will undergo ICSI utilizing ejaculated sperm.

Group Type ACTIVE_COMPARATOR

Ejaculate

Intervention Type OTHER

Ejaculate processing for ICSI

Testicular

Patients within this arm will undergo ICSI utilizing testicular sperm.

Group Type ACTIVE_COMPARATOR

Testicular sperm extraction (TESE)

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Ejaculate

Ejaculate processing for ICSI

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ganin Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eman Hasanen

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hosam Zaki, FRCOG

Role: STUDY_CHAIR

Ganin Fertility Center

Refaat Gabre, PhD

Role: STUDY_DIRECTOR

Faculty of Science, Cairo University

Mohamed Abbas

Role: STUDY_CHAIR

Cairo University

Nahla Osama, Phd

Role: STUDY_CHAIR

Faculty of Science, Cairo University

Locations

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Ganin Fertility Center

Cairo, Maadi, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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GFC-009

Identifier Type: -

Identifier Source: org_study_id

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