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

Not Applicable

Recruiting

• Conditions: Male Infertility
• Interventions: Procedure: Testicular sperm extraction (TESE); Other: Ejaculate

• Registration Number: NCT06476379
• Lead Sponsor: Ganin Fertility Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Study Start: 2024-06-25
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testicular	Testicular sperm extraction (TESE)	Patients within this arm will undergo ICSI utilizing testicular sperm.
Ejaculate	Ejaculate	Patients within this arm will undergo ICSI utilizing ejaculated sperm.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, Maadi, Egypt