Successful Pregnancy and Delivery After AOA

Infertility Clinical Trial

Official title:

Successful Pregnancy and Delivery After AOA in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01595815
• Other study ID #: GJHS120509DK
• Status: Active, not recruiting
• Phase: N/A
• First received: May 9, 2012
• Last updated: January 6, 2014
• Start date: May 2007
• Est. completion date: April 2016

Study information

• Verified date: January 2014
• Source: Maria Fertility Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Calcium ionophore
Oocytes were activated with calcium ionophore after ICSI
• Strontium chloride (SrCl2)
Oocytes were activated with strontium chloride after ICSI

Locations

Country	Name	City	State
Korea, Republic of	Maria Fertility Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Maria Fertility Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate		18 hours	Yes
Secondary	Embryo quality		3 Days	Yes
Secondary	Pregnancy and Implantation rates		2 months	Yes
Secondary	Assessment of Infant health care	This assessment is according to the standard set by the National Health Insurance Service (NHIS) in Korea.	birth and at 3, 6, 12, 24, 36, 60, and 72 months	Yes