Successful Pregnancy and Delivery After AOA

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: January 6, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Infertility
Other: Calcium ionophore
Other: Strontium chloride (SrCl2)

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 AOA in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates

Resource links provided by NLM:


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 Infant health care [ Time Frame: birth and at 3, 6, 12, 24, 36, 60, and 72 months ] [ Designated as safety issue: Yes ]
    This assessment is according to the standard set by the National Health Insurance Service (NHIS) in Korea.


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
Active Comparator: Conventional ICSI
The couple showed complete fertilization failure after ICSI.
Other: Calcium ionophore
Oocytes were activated with calcium ionophore after ICSI
Other: Strontium chloride (SrCl2)
Oocytes were activated with strontium chloride after ICSI
Active Comparator: Convention ICSI
The couple showed a low fertilization rates after ICSI.
Other: Calcium ionophore
Oocytes were activated with calcium ionophore after ICSI
Other: Strontium chloride (SrCl2)
Oocytes were activated with strontium chloride 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 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

Exclusion Criteria:

  • 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
  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: January 6, 2014
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 April 17, 2014