Efficacy of Oocyte Activation With Two Types of Ca2+ Ionophore. (Calcifer)

March 11, 2024 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

Efficacy of Oocyte Activation With Two Types of Ca2+ Ionophore: a Prospective Randomized Study.

This study is a prospective ranzomized analysis including 372 human oocytes from 44 women. Half of the oocytes from the same patient will be randomly allocated to induce oocyte activation using two protocols: in protocol nº 1 we will use ionomycin (prepared solution), protocol nª2 A23187 (GM508 CultActive Gynemed) will be applied. Non treated oocytes will serve as control. Oocyte fertilization rates, embryo development and embryo quality will be analyzed. Obstetrics variables of offspring will be also followed and compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Oocyte non-activation (OAD) is the main cause of fertilization failure in intracytoplasmic sperm injection (ICSI) cycles. Oocyte activation involves a series of consecutive events that take place in the oocyte during fertilization, triggered by the action of sperm-specific phospholipase C zeta (PLCz) that causes an increase in the amount of free Ca2+. This increase, as well as its transient elevations in space and time, is species-specific. Defects in this pattern of Ca2+ release and oscillation are attributed to most cases of OAD. Several strategies have been described and applied to achieve artificial oocyte activation (AOA), which use mechanical, electrical, or chemical stimuli, among which the use of calcium ionophores such as ionomycin and A23187 (calcimycin) predominates. Documented fertilization and pregnancy rates appear to be improved in patients with previous low fertilization rates or total fertilization failures after using ICSI-AOA compared to conventional ICSI. However, the lack of well-designed studies, the heterogeneity of the population undergoing AOA, and the scarcity of results comparing different AOA protocols make it difficult to assess the clinical efficacy and safety of the technique.

Study question: In patients with prior fertilization failure or low fertilization rates (30% or less), does AOA improve reproductive outcomes compared to conventional ICSI in patients with prior fertilization failure? and if it does, which protocol is more efficient?

Study Type

Interventional

Enrollment (Estimated)

44

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 Contact

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • Recruiting
        • Ivirma Valencia
        • Principal Investigator:
          • Maria Jose Delossantos, PhD
        • Contact:
        • Sub-Investigator:
          • Alberto Tejera
        • Sub-Investigator:
          • Thamara Viloria
        • Sub-Investigator:
          • Pilar Gámiz
        • Sub-Investigator:
          • Julia Gil
        • Sub-Investigator:
          • Sonia Pérez
        • Sub-Investigator:
          • M. Fernanda Insua
        • Sub-Investigator:
          • Arancha Galan
        • Sub-Investigator:
          • Alberto Pacheco

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Own oocyte patients who have had previous fertilization failure in previous cycles.
  • Own oocyte patients with fertilization rate in previous cycles less than or equal to 30% of the microinjected oocytes.

Exclusion Criteria:

  • Oocyte Recipient Patients
  • Sperm bank sperm recipient patients
  • Patients who after oocyte decumulation have less than 2 mature oocytes.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP 1 IONOMYCIN SIGMA
The oocytes obtained from the patients allocated to this group will be subdivided again in two groups Group 1a: Oocytes treated with SIGMA ionomycin (treatment). Group 1b: Oocytes that will not be treated with any activator (Control).
Drug: Ionomycin SIGMA
Oocytes will be activated with Ionomycin SIGMA
Active Comparator: GROUP 2 A23187
The oocytes obtained from the patients allocated to this group will be subdivided again in two groups Group 2a: Oocytes treated with A23187 (treatment). Group 2b: Oocytes that will not be treated with any activator (Control).
Drug: A23187
Oocytes will be activated with A23187

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the percetage of usable blastocyst per injeected oocyte
Time Frame: 1 YEAR
To evaluate which AOA protocol with the use of two calcium (Ca2+) ionophores, ionomycin and A23187 (calcimycin), is better (improvement from 15% to 25%)
1 YEAR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of PLCZ in sperm cells by flow
Time Frame: 1 year
To quantify PLCZ in sperm
1 year
Sequencing unfertilized oocytes and arrested embryos using RNAseq
Time Frame: 1 year
To quantify sequenced oocytes and arrested embryos after using RNAseq
1 year

Collaborators and Investigators

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

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

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 (Actual)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2303-VLC-043-MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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