NCT02424214

Brief Summary

Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

April 18, 2015

Last Update Submit

February 15, 2018

Conditions

Oocyte Fertilization

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate ( % )

    9 months

Secondary Outcomes (1)

  • Blastocyst rate ( % )

    9 months

Study Arms (3)

Ca Ionophore group

EXPERIMENTAL

Artificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection

Other: Artificial Oocyte activationDrug: Ca Ionophore

Strontium Chloride group

EXPERIMENTAL

Artificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection

Other: Artificial Oocyte activationDrug: Strontium Chloride

Only Intracytoplasmic Sperm Injection

NO INTERVENTION

after Intracytoplasmic Sperm Injection Oocytes will cultured and incubated

Interventions

Artificial Oocyte activationOTHER
Ca Ionophore groupStrontium Chloride group
Ca IonophoreDRUG
Ca Ionophore group
Strontium ChlorideDRUG
Strontium Chloride group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • previous fertilization failure
  • poor quality Oocytes
  • poor sperms

You may not qualify if:

  • normal patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Al Barka fertility center

Manama, Bahrain

Location

Banon Fertility Center

Asyut, Egypt

Location

Ibnsina IVF center

Sohag, Egypt

Location

Related Publications (1)

  • Fawzy M, Emad M, Mahran A, Sabry M, Fetih AN, Abdelghafar H, Rasheed S. Artificial oocyte activation with SrCl2 or calcimycin after ICSI improves clinical and embryological outcomes compared with ICSI alone: results of a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1636-1644. doi: 10.1093/humrep/dey258.

    PMID: 30099496DERIVED

MeSH Terms

Interventions

strontium chloride

Study Design

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

Study Record Dates

First Submitted

April 18, 2015

First Posted

April 22, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

EG(2)BA(1)