NCT03666364

Brief Summary

Women over 35 years old are likely to suffer from impaired oocyte repair capacity. Teratozoospermia is a condition reflects morphological affection of sperm. These spermatozoa would add an extra burden on the oocyte after ICSI. Whether selecting mature sperm by magnetic nanoparticle protocol would provide a more competent sperm to a likely affected oocyte would improve ICSI outcomes is the question of this research.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

September 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

September 9, 2018

Last Update Submit

November 14, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Twelve weeks of gestation

Secondary Outcomes (1)

  • Embryo development after ICSI

    Six days of culture

Study Arms (2)

Magnetic nanoparticle selection for teratozoospermia

EXPERIMENTAL
Other: Sperm preparation for ICSI

Density gradient centrifugation for teratozoospermia

NO INTERVENTION

Interventions

Sperm preparation for ICSIOTHER

A new protocol for sperm preparation for ICSI cycles with teratozoospermia in over 35 years old women

Magnetic nanoparticle selection for teratozoospermia

Eligibility Criteria

Age35 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women indicated for ICSI but with teratozoospermia

You may not qualify if:

  • Women not failing in this group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qena Fertility Center

Qina, Qena Governorate, 123456, Egypt

Location

Banon Assiut

Asyut, Egypt

Location

IbnSina IVF Center

Sohag, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

September 9, 2018

First Posted

September 11, 2018

Study Start

September 17, 2018

Primary Completion

September 20, 2019

Study Completion

October 1, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)