Clinical trial NCT06231589: PGT-A Evaluates Advanced Sperm Selection in Embryos From High Teratozoospermia Males
Official title: Next Generation Sequencing of Embryos for Testing the Efficacy of Advanced Sperm Selection Techniques in Males With High Teratozoospermia Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teratozoospermia
Sperm DNA Fragmentation
Infertility
Keywords: Sperm selection
Teratozoospermia index
Sperm DNA fragmentation
PGT-A
Euploidy rate
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study of 264 couples, sperm selection techniques in males with high teratozoospermia index and sperm DNA fragmentation significantly increased fertilization, blastocyst development rates, and maintained comparable embryo euploidy rates through preimplantation genetic testing, suggesting the efficiency of these techniques in improving assisted reproductive outcomes.

Detailed description: Couples seeking infertility treatment are becoming more frequent. Paternal factor shows one of the infertility causes which may have a negative impact on reproductive outcomes. Intracytoplasmic sperm injection (ICSI) is thought to be the most effective way to treat infertility. Sperm morphology evaluation is a reliable predictor of male fertility while teratozoospermia index (TZI) is a unique expression of sperm morphological assessment. A higher rate of abnormal sperm morphology tends to have higher sperm chromosomal abnormality rates. The choice of high-quality sperm through sperm selection techniques is expected to improve ICSI outcomes. In this study, a total number of 264 couples were included and divided into 3 groups: (1) Males have normal TZI (Control group: 111 males have TZI \<1.6), (2) Males with high TZI and no sperm selection techniques are performed (NO-SS group: 63 males have TZI \>1.8), and (3) Males with high TZI and sperm selection techniques are performed (SS-group: 90 males have TZI \>1.8). The TZI was significantly (P\<0.000) higher in the NO-SS and SS-group as compared to the control group. The percentage of sperm DNA fragmentation SDF in the males of the SS group was significantly higher than the controls and NO-SS group (P=0.000). The fertilization (P=0. 039) and blastocyst development rates (P= 0. 041) are significantly higher in the SS group as compared to the NO-SS group in females aged \<35. A total of 1072 embryos were tested for preimplantation genetic testing for aneuploidy using NGS, although higher SDF in the males of the SS group, the embryo euploidy rates show that there is no significant difference between the SS group (56.35±3.46%) as compared to the control group (54.54±3.24%) and the NO-SS group (57.45±4.57%). In general, we found that sperm selection techniques are efficient techniques in increasing fertilization, blastocyst development rates, and euploidy rate in males with high teratozoospermia index and sperm DNA fragmentation combined.

Eligibility criteria: Inclusion Criteria:

1. Males diagnosed with normal and high teratozoospermia index.
2. Males with Mild to moderate OTA (oligoteratoasthenozoospermia).
3. Males aged 18-60 years.
4. Female aged 18-40 years.
5. Case must have PGT-A for all of her blastocysts.
6. Normo responder (\> 5 mature oocytes).
7. Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI.

Exclusion Criteria:

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

Primary outcomes:
measure: Fertilization rate
timeFrame: 1 day
measure: Blastocyst development rate
timeFrame: 5-6 days
measure: Euploidy rate
timeFrame: 15 days post ICSI
measure: Aneuploidy rate
timeFrame: 15 days post ICSI
Secondary outcomes:
measure: Blastocyst quality rate
timeFrame: 5-6 days
measure: Low mosaic rate
timeFrame: 15 days post ICSI
measure: High mosaic rate
timeFrame: 15 days post ICSI
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
state: Maadi
Study officials:
affiliation: Ganin Fertility Center
name: Mohamed Nasreldin, MSc.
role: STUDY_CHAIR
affiliation: Cairo University
name: Hanan Ramadan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helwan University
name: Maiada Moustafa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Mohamed Abas, MBB
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc, FRCOG
role: STUDY_DIRECTOR
References: