Clinical Application of Artificial Oocyte Activation Technique (AOA) in ART

NCT04519918 | Unknown

• 1 other identifier: AOA
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Oocyte activation is an imperative stage in the initiation of embryo development during the fertilization. Indeed, the entrance of sperm into the oocyte causes sequences of calcium oscillations in its cytoplasm, regulating a series of molecular events called oocyte activation. The intracytoplasmic sperm injection (ICSI) has allowed fertilization in couples with severe male factor infertility. But, there was still fertilization failure or low fertilization occurs in ICSI cycles. It has reported that insufficient of oocyte activation is the important cause of fertilization failure. Artificial oocyte activation (AOA) represents an effective technique, can restore the calcium oscillations to improve the fertilization. Here, the investigators explore the effective of different AOA methods including oocyte was injected CaCl2 or mechanical stimulated then treated with calcium ionophore.

Conditions

Fertilization

Keywords

Fertilization failure; Artificial Oocyte Activation (AOA); Calcium ionophore; Fertilization

Outcome Measures

Primary Outcomes (1)

• Efficacy of AOA on fertilization

  Assess the normal fertilization rate (2PN rate)

  12 months

Secondary Outcomes (2)

• Efficacy of AOA on embryo quality

  12 months

• Efficacy of AOA on clinical outcome

  24 months

Study Arms (3)

Standard ICSI procedure

NO INTERVENTION

a single spermatozoon was injected into the ooplasm.

Chemical oocyte activation

EXPERIMENTAL

After CaCl2 was injected, the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA.

Behavioral: AOA

Mechanical oocyte activation

EXPERIMENTAL

Mechanical stimulation was done before standard ICSI procedure, then the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA.

Behavioral: AOA

Interventions

AOA BEHAVIORAL

AOA represents an invasive non-physiological technique.

Chemical oocyte activation; Mechanical oocyte activation

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The patients suffered at least one complete fertilization failure or low fertilization rate after performing standard ICSI in previous cycle. Low fertilization was defined as less than 33% fertilization rate.
• The patients suffered at least 2 cycles complete fertilization failure or low fertilization rate after performing IVF in previous cycle. Low fertilization was defined as less than 33% fertilization rate.
• The sperm of the patients has the following characteristics: globozoospermia, acrosomal deletion or small, severe head deformity, etc.
• Sperm of testicular origin and/or sperm that has been freeze-thawed.
• The sperm was PLC-ζ missing.
• The MII oocytes were IVM cultured and/or freeze-thawed.
• The patients suffered at least 2 cycles no available embryos, because of the embryo development block or fragmentation.

You may not qualify if:

• Normal fertilization IVF/ICSI cycles.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

Study Officials

• Li Bo, Doctor

  Reproductive Medicine Center, Tangdu Hospital

  STUDY CHAIR

Central Study Contacts

Wang Ming, Master

CONTACT

8613259809290; wangmingbio@snnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 20, 2020
• Study Start: October 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2022
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

CN (1)