Artificial Assisted Activation Following in Fertilization Failure

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

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.

Study Overview

• Status: Unknown
• Conditions: Fertilization
• Intervention / Treatment: Behavioral: Artificial Assisted Activation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Ming, Master; Phone Number: 8613259809290; Email: wangmingbio@snnu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Standard ICSI procedure. The MII oocytes that failed fertilization in IVF cycles were injected with activating sperm.
Experimental: A1 assisted activation; The MII oocytes that failed fertilization in ICSI cycles were activated in calcium ionophore A23187 activation solution for two times.	Behavioral: Artificial Assisted Activation; Artificial assisted activation represents an effective technique to rescue the fertilization failure.
Experimental: A2 assisted activation; Fertilization failure MII oocytes were collected in ICSI cycles. After CaCl2 was injected, the oocytes were transferred into the calcium ionophore A23187 solution for two times.	Behavioral: Artificial Assisted Activation; Artificial assisted activation represents an effective technique to rescue the fertilization failure.
Experimental: A3 assisted activation; Fertilization failure MII oocytes were collected in ICSI cycles. Mechanical activation was done for the MII oocytes, and then the oocytes were transferred into the calcium ionophore A23187 solution for two times.	Behavioral: Artificial Assisted Activation; Artificial assisted activation represents an effective technique to rescue the fertilization failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the normal fertilization rate	Fertilization (2PN rate)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the good-quality embryo rate	Embryo quality	12 months
the blastocyst formation rate	Embryo quality	12 months
the good quality blastocyst rate	Embryo quality	12 months

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Study Chair: Li Bo, Doctor, Reproductive Medicine Center, Tangdu Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: fertilization failure, oocyte activation, calcium ionophore
• Other Study ID Numbers: A0728

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No