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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Pinar Caglar Aytac, Baskent University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02045914
First Posted: January 27, 2014
Last Update Posted: January 27, 2014
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.
Information provided by (Responsible Party):
Pinar Caglar Aytac, Baskent University
  Purpose
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

Condition Intervention
Fertilization Failure Other: calcium ionophore solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effect of Calcium Ionophore Solution on Fertilization Rate During ICSI Cycles of Poor Ovarian Reserve Patients

Resource links provided by NLM:


Further study details as provided by Pinar Caglar Aytac, Baskent University:

Primary Outcome Measures:
  • 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?


Secondary Outcome Measures:
  • 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?


Other Outcome Measures:
  • 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


Estimated Enrollment: 162
Study Start Date: January 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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?
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02045914


Contacts
Contact: Pinar Caglar Aytac, MD 905052796784 pinarcag1976@yahoo.com

Locations
Turkey
baskent university obstetric and gynecology, reproductive endocrinology and IVF unit Recruiting
Adana, Kisla, Turkey, 01230
Contact    903224597249      
Principal Investigator: pinar caglar aytac         
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pinar Caglar Aytac, Effect of calcium ionophore solution on fertilization rate during ICSI cycles of poor ovarian reserve patients, Baskent University
ClinicalTrials.gov Identifier: NCT02045914     History of Changes
Other Study ID Numbers: KA1-191
First Submitted: January 23, 2014
First Posted: January 27, 2014
Last Update Posted: January 27, 2014
Last Verified: January 2014

Keywords provided by Pinar Caglar Aytac, Baskent University:
calcium ionophore
fertilization rate
poor ovarian reserve

Additional relevant MeSH terms:
Pharmaceutical Solutions
Calcium, Dietary
Ionophores
Ionomycin
Calcium Ionophores
Bone Density Conservation Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action