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

NCT ID: NCT02045914

Last Updated: 2014-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-08-31

Brief Summary

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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

Detailed Description

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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?

Conditions

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Fertilization Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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control group

the patients who have no intervention with calcium ionophore during ICSI cycle

Group Type NO_INTERVENTION

No interventions assigned to this group

calcium ionophore

the patients whose oocytes are incubated with calcium ionophore solution during ICSI cycle

Group Type EXPERIMENTAL

calcium ionophore solution

Intervention Type OTHER

After microinjection of sperm into the oocyte, oocytes are incubated for 15 minutes in a 30 microlitre droplet of calcium ionomycin solution

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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GM 508 Cult-Active (Gynemed) ionomycin

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Pinar Caglar Aytac

Effect of calcium ionophore solution on fertilization rate during ICSI cycles of poor ovarian reserve patients

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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esra bulgan kilicdag, prof md

Role: STUDY_DIRECTOR

Baskent University

Huriye Ayse Parlakgumus, md

Role: STUDY_CHAIR

Baskent University

Pinar Caglar Aytac, md

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Cok Tayfun, md

Role: STUDY_CHAIR

Baskent University

Bulent Haydardedeoglu, assoc Prof

Role: STUDY_CHAIR

Baskent University

Erhan Simsek, md

Role: STUDY_CHAIR

Baskent University

Locations

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baskent university obstetric and gynecology, reproductive endocrinology and IVF unit

Adana, Kisla, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Pinar Caglar Aytac, MD

Role: CONTACT

905052796784

Facility Contacts

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Role: primary

903224597249

References

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Caglar Aytac P, Kilicdag EB, Haydardedeoglu B, Simsek E, Cok T, Parlakgumus HA. Can calcium ionophore "use" in patients with diminished ovarian reserve increase fertilization and pregnancy rates? A randomized, controlled study. Fertil Steril. 2015 Nov;104(5):1168-74. doi: 10.1016/j.fertnstert.2015.07.1163. Epub 2015 Sep 3.

Reference Type DERIVED
PMID: 26342247 (View on PubMed)

Other Identifiers

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KA1-191

Identifier Type: -

Identifier Source: org_study_id

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