Calcium Ionophore Solution Can Increase Fertilization Rate in Patients During Intracytoplasmic Sperm Injection(ICSI) Who Have Poor Ovarian Reserve?

January 23, 2014 updated by: Pinar Caglar Aytac, Baskent University

Effect of Calcium Ionophore Solution on Fertilization Rate During ICSI Cycles of Poor Ovarian Reserve Patients

The aim of this study is to evaluate calcium ionophore solution on fertilization rate of patients during intracytoplasmic sperm injection who have poor ovarian reserve

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

During ICSI cycle , female patients who have poor ovarian reserve have low oocyte numbers. So by calcium ionophore solution which we know that it can increase fertilization rate in males who have azospermia or globozoospermia. we planned to check if this solution can increase fertilization rate also in poor ovarian reserve patients?

Study Type

Interventional

Enrollment (Anticipated)

162

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

  • Turkey
    • Kisla
      • Adana, Kisla, Turkey, 01230
        • Recruiting
        • baskent university obstetric and gynecology, reproductive endocrinology and IVF unit
        • Contact:
          • Phone Number: 903224597249
        • Principal Investigator:
          • pinar caglar aytac

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

23 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • infertile couples who have no male factor infertility
  • infertile females who are poor ovarian reserve

Exclusion Criteria:

  • infertile couples who have male factor infertility
  • infertile female who have endometriosis

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
the patients who have no intervention with calcium ionophore during ICSI cycle
Experimental: calcium ionophore
the patients whose oocytes are incubated with calcium ionophore solution during ICSI cycle
Other: calcium ionophore solution
After microinjection of sperm into the oocyte, oocytes are incubated for 15 minutes in a 30 microlitre droplet of calcium ionomycin solution
Other Names:
  • GM 508 Cult-Active (Gynemed)
  • ionomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calcium ionophore solution effect on fertilization rate
Time Frame: 18 hours
Before Intracytoplasmic sperm injection adding calcium ionophore solution to the medium can increase fertilization rate of oocytes or not?
18 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium ionophore solution increase on going pregnancy rate
Time Frame: up to 21 weeks
İf the calcium ionophore can increase fertilization rate , pregnancy rate up to 20 weeks, can increase or not?
up to 21 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
calcium ionophore can decrease fertilization rate
Time Frame: 18 hours
To detect if calcium ionophore can affect fertilization rate in a reverse manner than expected
18 hours

Collaborators and Investigators

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

Sponsor

Baskent University

Investigators

  • Study Director: esra bulgan kilicdag, prof md, Baskent University
  • Study Chair: Huriye Ayse Parlakgumus, md, Baskent University
  • Principal Investigator: Pinar Caglar Aytac, md, Baskent University
  • Study Chair: Cok Tayfun, md, Baskent University
  • Study Chair: Bulent Haydardedeoglu, assoc Prof, Baskent University
  • Study Chair: Erhan Simsek, md, Baskent University

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

January 1, 2014

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA1-191

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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