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Successful Pregnancy and Delivery After Strontium Chloride Oocyte Activation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jun-Woo Kim, Principal Investigator, Maria Fertility Hospital
ClinicalTrials.gov Identifier:
NCT01595815
First received: May 9, 2012
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention
Infertility
 Other: Strontium chloride (SrCl2)
Other: Conventional ICSI with or without calcium ionophore

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Successful Pregnancy and Delivery After Strontium Chloride Oocyte Activation in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates Following Calcium Ionophore Treatment

Resource links provided by NLM:

MedlinePlus related topics: Calcium Infertility
U.S. FDA Resources

Further study details as provided by Maria Fertility Hospital:

Primary Outcome Measures:
  • Fertilization rate [ Time Frame: 18 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Embryo quality [ Time Frame: 3 Days ] [ Designated as safety issue: Yes ]
  • Pregnancy and Implantation rates [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Assessment of child development [ Time Frame: birth and at 3, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2007
Estimated Study Completion Date: April 2016
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strontium chloride (SrCl2)
Oocytes were activated with SrCl2 after ICSI
 Other: Strontium chloride (SrCl2)
Oocytes were activated with SrCl2 after ICSI
Active Comparator: Conventional ICSI with or without calcium ionophore
Oocytes were activated with or without calcium ionophore after ICSI
 Other: Conventional ICSI with or without calcium ionophore
Oocytes were activated with or without calcium ionophore after ICSI

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fertilization rate was less than 40% after conventional ICSI
  • Repeated complete fertilization failure or low fertilization rates following ICSI with or without calcium ionophore treatment in previous cycles

Exclusion Criteria:

  • Fertilization rate was more than 40% after conventional ICSI
  • Successful pregnancy and delivery after ICSI with or without calcium ionophore treatment in previous cycles
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595815

Locations
Korea, Republic of
Maria Fertility Hospital
Seoul, Korea, Republic of, 138-160
Sponsors and Collaborators
Maria Fertility Hospital
  More Information

No publications provided

Responsible Party: Jun-Woo Kim, Principal Investigator, Maria Fertility Hospital
ClinicalTrials.gov Identifier: NCT01595815     History of Changes
Other Study ID Numbers: GJHS120509DK
Study First Received: May 9, 2012
Last Updated: May 17, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Maria Fertility Hospital:
Fertilization failure, calcium ionophore, SrCl2

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Calcium, Dietary
Ionophores
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013