NCT01595815

Brief Summary

Artificial oocyte activation with strontium chloride or calcium ionophore improves fertilization, embryo quality, pregnancy and delivery rate in women who showed complete fertilization failure or low fertilization rates

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 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

May 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 9, 2025

Status Verified

January 1, 2014

Enrollment Period

4.3 years

First QC Date

May 9, 2012

Last Update Submit

May 6, 2025

Conditions

Keywords

Fertilization failure, calcium ionophore, SrCl2

Outcome Measures

Primary Outcomes (1)

  • Fertilization rate

    18 hours

Secondary Outcomes (3)

  • Embryo quality

    3 Days

  • Pregnancy and Implantation rates

    2 months

  • Assessment of Infant health care

    birth and at 3, 6, 12, 24, 36, 60, and 72 months

Study Arms (2)

Conventional ICSI

ACTIVE COMPARATOR

The couple showed complete fertilization failure after ICSI.

Other: Calcium ionophoreOther: Strontium chloride (SrCl2)

Convention ICSI

ACTIVE COMPARATOR

The couple showed a low fertilization rates after ICSI.

Other: Calcium ionophoreOther: Strontium chloride (SrCl2)

Interventions

Oocytes were activated with calcium ionophore after ICSI

Convention ICSIConventional ICSI

Oocytes were activated with strontium chloride after ICSI

Convention ICSIConventional ICSI

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fertilization rate was less than 30% after conventional ICSI.
  • Fertilization rate was less than 50% after ICSI with calcium ionophore.
  • Repeated complete fertilization failure or low fertilization rates following ICSI in previous cycles

You may not qualify if:

  • Fertilization rate was more than 30% after conventional ICSI
  • Fertilization rate was more than 50% after ICSI with calcium ionophore.
  • Successful pregnancy and delivery after ICSI in previous cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Fertility Hospital

Seoul, 138-160, South Korea

Location

Related Publications (1)

  • Kim JW, Yang SH, Yoon SH, Kim SD, Jung JH, Lim JH. Successful pregnancy and delivery after ICSI with artificial oocyte activation by calcium ionophore in in-vitro matured oocytes: a case report. Reprod Biomed Online. 2015 Apr;30(4):373-7. doi: 10.1016/j.rbmo.2014.11.014. Epub 2014 Dec 11.

MeSH Terms

Conditions

Infertility

Interventions

Calcium Ionophoresstrontium chloride

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

IonophoresMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maria Fertility Hospital

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

May 1, 2007

Primary Completion

September 1, 2011

Study Completion

April 1, 2014

Last Updated

May 9, 2025

Record last verified: 2014-01

Locations