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Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study (GM508 in IVF)

Primary Purpose

IVF, Infertility, Artificial Oocyte Activation

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
calcium ionophore
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IVF focused on measuring artificial oocyte activation, calcium ionophore, ivf, poor responder

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

oocytes treated with calcium ionophore

oocytes undergo routine IVF/ICSI protocol

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blastocyst formation rate
NO. of blastocysts per 2PN zygotes
top-quality blastocyst formation rate
No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes
pregnancy outcome
pregnancy rates, abortion rate, live birth rates,congenital anomaly rate

Full Information

First Posted
November 20, 2022
Last Updated
February 8, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05722067
Brief Title
Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study
Acronym
GM508 in IVF
Official Title
Improved the Low Fertilization Rates and Increased the High-quality Embryogenesis by Treatment With Calcium Ionophore GM508 CultActive Optimized Medium in Vitro Fertilization (IVF) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IVF, Infertility, Artificial Oocyte Activation
Keywords
artificial oocyte activation, calcium ionophore, ivf, poor responder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oocytes treated with calcium ionophore
Arm Type
Experimental
Arm Description
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.
Arm Title
oocytes undergo routine IVF/ICSI protocol
Arm Type
No Intervention
Arm Description
Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine.
Intervention Type
Other
Intervention Name(s)
calcium ionophore
Other Intervention Name(s)
GM508 CultActive
Intervention Description
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.
Primary Outcome Measure Information:
Title
fertilization rate
Description
The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
blastocyst formation rate
Description
NO. of blastocysts per 2PN zygotes
Time Frame
Day 5
Title
top-quality blastocyst formation rate
Description
No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes
Time Frame
Day 5
Title
pregnancy outcome
Description
pregnancy rates, abortion rate, live birth rates,congenital anomaly rate
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
123
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuo-Chung Lan, PhD
Phone
+886-975056415
Email
lankuochung@gmail.com
First Name & Middle Initial & Last Name & Degree
Ni-Chin Tsai, MD
Phone
+886-975369271
Email
ninytsai@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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