Efficacy of Oocyte Activation With Two Types of Ca2+ Ionophore.

NCT06106412 | Recruiting

• 1 other identifier: 2303-VLC-043-MD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Female

Keywords

Artificial oocyte activation; Fertilization Failure; Calcium ionophore; Ionomycin; Calcimycin; Fertilization rate

Outcome Measures

Primary Outcomes (1)

• Improvement in the percetage of usable blastocyst per injeected oocyte

  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 Outcomes (2)

• Sequencing unfertilized oocytes and arrested embryos using RNAseq

  1 year

• Quantification of PLCZ in sperm cells by flow

  1 year

Study Arms (2)

GROUP 1 IONOMYCIN SIGMA

EXPERIMENTAL

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

GROUP 2 A23187

ACTIVE COMPARATOR

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

Interventions

Ionomycin SIGMA DRUG

Oocytes will be activated with Ionomycin SIGMA

GROUP 1 IONOMYCIN SIGMA

A23187 DRUG

Oocytes will be activated with A23187

GROUP 2 A23187

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Ivirma Valencia

Valencia, 46015, Spain

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Calcimycin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Polyether Polyketides; Ethers, Cyclic; Ethers; Organic Chemicals; Polyketides; Lactones; Benzoxazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

LAURA CARACENA, Msr

CONTACT

963.050900; LAURA.CARACENA@IVIRMA.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective ranzomized analysis

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

ES (1)