We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Successful Pregnancy and Delivery After AOA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01595815
Recruitment Status : Unknown
Verified January 2014 by Jun-Woo Kim, Principal Investigator, Maria Fertility Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 10, 2012
Last Update Posted : January 8, 2014
Sponsor:
Information provided by (Responsible Party):
Jun-Woo Kim, Principal Investigator, Maria Fertility Hospital

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

Condition or disease Intervention/treatment
Infertility Other: Calcium ionophore Other: Strontium chloride (SrCl2)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Successful Pregnancy and Delivery After AOA in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates
Study Start Date : May 2007
Primary Completion Date : September 2011
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Fertilization rate [ Time Frame: 18 hours ]

Secondary Outcome Measures :
  1. Embryo quality [ Time Frame: 3 Days ]
  2. Pregnancy and Implantation rates [ Time Frame: 2 months ]
  3. Assessment of Infant health care [ Time Frame: birth and at 3, 6, 12, 24, 36, 60, and 72 months ]
    This assessment is according to the standard set by the National Health Insurance Service (NHIS) in Korea.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595815


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jun-Woo Kim, Principal Investigator, Maria Fertility Hospital
ClinicalTrials.gov Identifier: NCT01595815     History of Changes
Other Study ID Numbers: GJHS120509DK
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014

Keywords provided by Jun-Woo Kim, Principal Investigator, Maria Fertility Hospital:
Fertilization failure, calcium ionophore, SrCl2

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