Artificial Assisted Activation Following in Fertilization Failure

Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04523103
• Other study ID #: A0728
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fertilization

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