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

NCT ID: NCT05722067

Last Updated: 2025-02-20

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

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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IVF Infertility Artificial Oocyte Activation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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oocytes treated with calcium ionophore

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.

Group Type EXPERIMENTAL

calcium ionophore

Intervention Type 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.

oocytes undergo routine IVF/ICSI protocol

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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calcium ionophore

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.

Intervention Type OTHER

Other Intervention Names

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GM508 CultActive

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Without or just one oocyte picked up
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Kuo-Chung Lan, PhD

Role: primary

+886-975056415

Ni-Chin Tsai, MD

Role: backup

+886-975369271

Other Identifiers

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202200969A3

Identifier Type: -

Identifier Source: org_study_id

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