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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04523103
Other study ID # A0728
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date September 30, 2021

Study information

Verified date September 2020
Source Tang-Du Hospital
Contact Wang Ming, Master
Phone 8613259809290
Email wangmingbio@snnu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date September 30, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Artificial Assisted Activation
Artificial assisted activation represents an effective technique to rescue the fertilization failure.

Locations

Country Name City State
China Tangdu Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the normal fertilization rate Fertilization (2PN rate) 12 months
Secondary the good-quality embryo rate Embryo quality 12 months
Secondary the blastocyst formation rate Embryo quality 12 months
Secondary the good quality blastocyst rate Embryo quality 12 months
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