Overview

This trial is active, not recruiting.

Condition infertility
Treatments calcium ionophore, strontium chloride (srcl2)
Sponsor Maria Fertility Hospital
Start date May 2007
End date September 2011
Trial size 100 participants
Trial identifier NCT01595815, GJHS120509DK

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
The couple showed complete fertilization failure after ICSI.
calcium ionophore
Oocytes were activated with calcium ionophore after ICSI
strontium chloride (srcl2)
Oocytes were activated with strontium chloride after ICSI
(Active Comparator)
The couple showed a low fertilization rates after ICSI.
calcium ionophore
Oocytes were activated with calcium ionophore after ICSI
strontium chloride (srcl2)
Oocytes were activated with strontium chloride after ICSI

Primary Outcomes

Measure
Fertilization rate
time frame: 18 hours

Secondary Outcomes

Measure
Embryo quality
time frame: 3 Days
Pregnancy and Implantation rates
time frame: 2 months
Assessment of Infant health care
time frame: birth and at 3, 6, 12, 24, 36, 60, and 72 months

Eligibility Criteria

Female participants from 20 years up to 45 years old.

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

Additional Information

Official title Successful Pregnancy and Delivery After AOA in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Maria Fertility Hospital.