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Clinical Trials/NCT04523103
NCT04523103
Unknown
Not Applicable

Clinical Study of Artificial Assisted Oocyte Activation Technique in IVF Fertilization Failure

Tang-Du Hospital1 site in 1 country200 target enrollmentNovember 1, 2020
ConditionsFertilization

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fertilization
Sponsor
Tang-Du Hospital
Enrollment
200
Locations
1
Primary Endpoint
the normal fertilization rate
Last Updated
5 years ago

Overview

Brief Summary

Fertilization failure is a common problem in assisted reproductive Technology (ART). The main reason for fertilization failure of conventional IVF fertilization is sperm penetration failure, and the main reason of ICSI is insufficient oocyte activation. Artificial assisted activation may provide an effective technique to rescue fertilization failure. In this study, standard ICSI procedures were applied to save fertilization failure of unfertilized mature oocytes in IVF cycles. The unfertilized mature oocytes after ICSI were activated by calcium ion, or injected with calcium chloride/activated with mechanical stimulated and then transfer to calcium ion to improve fertilization. In this study, different artificial assisted activation methods were used to save the fertilization failure and assess its effective and subsequent embryo development potential.

Detailed Description

A variety of mechanical, electrical, and chemical methods has been used to trigger the calcium oscillations to activate oocytes. Mechanical and chemical activation are the most commonly used methods for artificial oocyte activation, which can mimic calcium oscillations saving fertilization failure. Control group, a single spermatozoon was injected into the failed fertilization MII oocyte in conventional IVF cycle. What to do when ICSI fails? The investigators collected the unfertilized MII oocytes and divided them into 3 groups to perform different activation methods, including chemical calcium ionophore activation (experiment group 1), CaCl2 injected combined with calcium ionophore activation (experiment group 2), and mechanical stimulation combined with calcium ionophore activation (experiment group 3). Calcium ionophore A23187 (Sigma) was used for assisted activation. The final solution was 10 μmol/L. The oocytes were exposed to the calcium ionophore A23187 for 10 min at 37°C in 5% CO2. The oocytes were checked for pronucleus formation at 16-20 hours after activation. Fertilized oocytes were cultured in vitro for 3-5 days, the developmental potential of the activated embryos were observed. This study want to explore the effective of different artificial assisted activation methods, to improve the fertilization outcome of unfertilized oocytes after ICSI or IVF.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
September 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Tang-Du Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 8 ≤ Number of retrieved oocytes ≤ 20;
  • 18.5\< Body Mass Index (BMI) \<25;
  • The patients who suffered complete fertilization failure or low fertilization after performing standard ICSI/IVF cycle. Low fertilization was defined as less than 33% fertilization rate.

Exclusion Criteria

  • Normal fertilization IVF/ICSI cycle.

Outcomes

Primary Outcomes

the normal fertilization rate

Time Frame: 12 months

Fertilization (2PN rate)

Secondary Outcomes

  • the good-quality embryo rate(12 months)
  • the good quality blastocyst rate(12 months)
  • the blastocyst formation rate(12 months)

Study Sites (1)

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