NCT06231589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

January 21, 2024

Last Update Submit

January 29, 2024

Conditions

TeratozoospermiaSperm DNA FragmentationInfertility

Keywords

Sperm selectionTeratozoospermia indexSperm DNA fragmentationPGT-AEuploidy rate

Outcome Measures

Primary Outcomes (4)

  • Fertilization rate

    Defined as the proportion of fertilizaed oocytes

    1 day

  • Blastocyst development rate

    Defined as the proportion of blastocysts formed on day 5 or 6

    5-6 days

  • Euploidy rate

    Defined as the proportion of euploid blastocysts

    15 days post ICSI

  • Aneuploidy rate

    Defined as the proportion of aneuploid blastocysts

    15 days post ICSI

Secondary Outcomes (3)

  • Blastocyst quality rate

    5-6 days

  • Low mosaic rate

    15 days post ICSI

  • High mosaic rate

    15 days post ICSI

Study Arms (3)

Control

NO INTERVENTION

111 Males have normal Teratozoospermia index (TZI) less than 1.6. Semen processing is done by double layer density gradient method only.

Sperm selection group PICSI or MACS (SS-Group)

EXPERIMENTAL

90 Males with high TZI and sperm selection techniques such as PICSI or MACS are performed. Semen processing is done by double layer density gradient method followed by: (1) In case of PICSI: adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Individual bound sperm selection is done followed by ICSI. or (2) In case of MACS: Semen processing is done by double layer density gradient method. The resulted pellet is labeled with annexin V microbeads followed by separation on MACS Column, the eluted fraction contains non apoptotic sperm suitable for ICSI.

Device: Sperm Selection

No sperm selection group (NO SS-Group)

NO INTERVENTION

63 Males with high TZI more than 1.8 and no sperm selection techniques are performed. Semen processing is done by double layer density gradient method only.

Interventions

Sperm SelectionDEVICE

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.

Sperm selection group PICSI or MACS (SS-Group)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males diagnosed with normal and high teratozoospermia index.
  • Males with Mild to moderate OTA (oligoteratoasthenozoospermia).
  • Males aged 18-60 years.
  • Female aged 18-40 years.
  • Case must have PGT-A for all of her blastocysts.
  • Normo responder (\> 5 mature oocytes).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

Location

MeSH Terms

Conditions

TeratozoospermiaInfertility

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mohamed Nasreldin, MSc.

    Ganin Fertility Center

    STUDY CHAIR

  • Hanan Ramadan, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Maiada Moustafa, PhD

    Helwan University

    PRINCIPAL INVESTIGATOR

  • Mohamed Abas, MBB

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Hosam Zaki, MSc, FRCOG

    Ganin Fertility Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Embryologist

Study Record Dates

First Submitted

January 21, 2024

First Posted

January 30, 2024

Study Start

January 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

EG(1)