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

Study Overview
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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).

Official Title
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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

Conditions
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IVF, Infertility, Artificial Oocyte Activation

Intervention / Treatment
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* Other: calcium ionophore


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oocytes treated with calcium ionophore<br>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<br>* 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.<br>* Other names: GM508 CultActive;|
| No Intervention: oocytes undergo routine IVF/ICSI protocol<br>Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blastocyst formation rate | NO. of blastocysts per 2PN zygotes | Day 5 | 
| top-quality blastocyst formation rate | No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes | Day 5 | 
| pregnancy outcome | pregnancy rates, abortion rate, live birth rates,congenital anomaly rate | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial oocyte activation, calcium ionophore, ivf, poor responder