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OpenTrials
Completed

NCT Number: NCT05722067

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

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).

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Key information

Conditions

IVF Artificial Oocyte Activation Genital Diseases Infertility Long Qt Syndrome 3 Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Kaohsiung City, 123, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: GM508 CultActive

Primary outcomes

  1. fertilization rate

    Time frame: Day 1

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

Secondary outcomes

  1. blastocyst formation rate

    Time frame: Day 5

    NO. of blastocysts per 2PN zygotes

  2. top-quality blastocyst formation rate

    Time frame: Day 5

    No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes

  3. pregnancy outcome

    Time frame: 1 year

    pregnancy rates, abortion rate, live birth rates,congenital anomaly rate

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Acronym: GM508 in IVF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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