PGT-A Evaluates Advanced Sperm Selection in Embryos From High Teratozoospermia Males

Infertility Clinical Trial

Official title:

Next Generation Sequencing of Embryos for Testing the Efficacy of Advanced Sperm Selection Techniques in Males With High Teratozoospermia Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06231589
• Other study ID #: GFC-008
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2024
• Source: Ganin Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Sperm DNA Fragmentation
• Teratozoospermia

Intervention

Device:
• Sperm Selection
Sperm selection using physiological intracytoplasmic sperm injection (PICSI dish) or magnetic-activated cell sorting (MACS) for selecting sperm with high-quality, better morphology and lower DNA fragmentation.

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate	Defined as the proportion of fertilizaed oocytes	1 day
Primary	Blastocyst development rate	Defined as the proportion of blastocysts formed on day 5 or 6	5-6 days
Primary	Euploidy rate	Defined as the proportion of euploid blastocysts	15 days post ICSI
Primary	Aneuploidy rate	Defined as the proportion of aneuploid blastocysts	15 days post ICSI
Secondary	Blastocyst quality rate	Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor	5-6 days
Secondary	Low mosaic rate	Defined as the proportion of low mosaic blastocysts	15 days post ICSI
Secondary	High mosaic rate	Defined as the proportion of high mosaic blastocysts	15 days post ICSI