Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study

NCT05722067 | Completed

• 1 other identifier: 202200969A3
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

GM508 CultActive is a bicarbonate buffered reagent and ready-to-use designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles. The investigators hypothesize that GM508 CultActive will improve the fertilization rate and embryo development of such IVF patients (a history of poor fertilization, a history of poor embryo quality, and over 40 years old expected challenging to conceive).

Conditions

IVF; Infertility; Artificial Oocyte Activation

Keywords

artificial oocyte activation; calcium ionophore; ivf; poor responder

Outcome Measures

Primary Outcomes (1)

• fertilization rate

  The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes

  Day 1

Secondary Outcomes (3)

• blastocyst formation rate

  Day 5

• top-quality blastocyst formation rate

  Day 5

• pregnancy outcome

  1 year

Study Arms (2)

oocytes treated with calcium ionophore

EXPERIMENTAL

Oocytes treated with a ready-to-use ionophore compound (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF). After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes subjected to AOA will transfer to the same time-lapse culture dish with the controlled sibling group.

Other: calcium ionophore

oocytes undergo routine IVF/ICSI protocol

NO INTERVENTION

Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine.

Interventions

calcium ionophore OTHER

The intervention group will be treated with a ready-to-use ionophore medium (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF) based on the situation of sperm. After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes will be cultured in the same protocol as the control group.

Also known as: GM508 CultActive

oocytes treated with calcium ionophore

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Low fertilization rate in previous IVF cycle (\<30%), or
• Poor embryo developmental problems in previous IVF cycle, or
• Diminished ovarian reserve (AMH\<1.2 or AFC\<5) and/or more than 40 y/o.

You may not qualify if:

• Without or just one oocyte picked up

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 123, Taiwan

Location

MeSH Terms

Conditions

Infertility; Long Qt Syndrome 3

Interventions

Calcium Ionophores

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ionophores; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: February 10, 2023
• Study Start: January 1, 2023
• Primary Completion: March 23, 2025
• Study Completion: June 30, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)