NCT02418416

Brief Summary

Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
2 countries

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

April 6, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

May 6, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

April 6, 2015

Last Update Submit

September 25, 2018

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy rate ( % )

    To predict percentage of pregnant women from those will undergo Embryo transfer

    3 months

Secondary Outcomes (1)

  • Blastocyst rate ( % )

    3 months

Study Arms (2)

Double activation

EXPERIMENTAL

The Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min.

Other: Oocyte double chemical activation

Control arm

NO INTERVENTION

The Oocytes will undergo Intracytoplasmic sperm injection only

Interventions

Oocyte double chemical activationOTHER

Oocyte double chemical activation

Double activation

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • poor sperm
  • poor quality Oocytes
  • previous failed fertilization
  • previous poor embryogenesis

You may not qualify if:

  • normal patient
  • previous successful outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Al Barka fertility center

Bahrain, Bahrain

Location

Banon fertility center

Asyut, Egypt

Location

IbnSina IVF unit, IbnSina Hospital, El Areef Square

Sohag, 12345, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Laboratory Director

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 16, 2015

Study Start

May 6, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations

BA(1)EG(2)