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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Baskent University
Sponsor:
Information provided by (Responsible Party):
Pinar Caglar Aytac, Baskent University
ClinicalTrials.gov Identifier:
NCT02045914
First received: January 23, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Baskent University:

Primary Outcome Measures:
  • calcium ionophore solution effect on fertilization rate [ Time Frame: 18 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   23 Years to 39 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 23, 2014
Last Updated: January 23, 2014
Health Authority: Turkey: Ethics Committee

Keywords provided by Baskent University:
calcium ionophore
fertilization rate
poor ovarian reserve

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

ClinicalTrials.gov processed this record on September 16, 2014