Artificial Assisted Activation Following in Fertilization Failure

NCT04523103 | Unknown

• 1 other identifier: A0728
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertilization

Keywords

fertilization failure, oocyte activation, calcium ionophore

Outcome Measures

Primary Outcomes (1)

• the normal fertilization rate

  Fertilization (2PN rate)

  12 months

Secondary Outcomes (3)

• the good-quality embryo rate

  12 months

• the blastocyst formation rate

  12 months

• the good quality blastocyst rate

  12 months

Study Arms (4)

Control group

NO INTERVENTION

Standard ICSI procedure. The MII oocytes that failed fertilization in IVF cycles were injected with activating sperm.

A1 assisted activation

EXPERIMENTAL

The MII oocytes that failed fertilization in ICSI cycles were activated in calcium ionophore A23187 activation solution for two times.

Behavioral: Artificial Assisted Activation

A2 assisted activation

EXPERIMENTAL

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

A3 assisted activation

EXPERIMENTAL

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

Interventions

Artificial Assisted Activation BEHAVIORAL

Artificial assisted activation represents an effective technique to rescue the fertilization failure.

A1 assisted activation; A2 assisted activation; A3 assisted activation

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≤ Number of retrieved oocytes ≤ 20;
• \< 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.

You may not qualify if:

• Normal fertilization IVF/ICSI cycle.

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: August 19, 2020
• First Posted: August 21, 2020
• Study Start: November 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: September 30, 2021
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

CN (1)