Successful Pregnancy and Delivery After AOA

January 6, 2014 updated by: Jun-Woo Kim, Principal Investigator, Maria Fertility Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fertilization rate
Time Frame: 18 hours
18 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo quality
Time Frame: 3 Days
3 Days
Pregnancy and Implantation rates
Time Frame: 2 months
2 months
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.
birth and at 3, 6, 12, 24, 36, 60, and 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Fertility Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (ESTIMATE)

May 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GJHS120509DK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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