AOA in Recurrent Fertilization Failure

NCT04744753 | Completed Phase 4 DMC

• 1 other identifier: 202010454
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite the high success rate of ICSI, total fertilization failure still occurs in 1-3% of all ICSI cycles and can recur in subsequent cycles, even when a sufficient number of oocytes and motile spermatozoa are available. Several reports show that the majority of couples suffering from ICSI failure benefit from the application of ICSI combined with assisted oocyte activation. A variety of artificial activating methods is used in human assisted reproduction treatment, including physical, mechanical or chemical stimuli, which provoke one or more calcium rises in the oocyte cytoplasm. Study Design: Randomized controlled trial. Setting: A university fertility center. Methods: 150 infertile patients who underwent ICSI and all had history of recurrent fertilization failure. The patients were randomly allocated into 2 equal groups. Group1=75 patients who underwent ICSI without oocyte activation. Group2 patients =75 and underwent ICSI Patient underwent ICSI with oocyte activation. Reproductive outcomes were compared between both groups. Results: there were significant differences between groups regarding number of oocytes retrieved, number of mature oocyte, fertilization rate and pregnancy rate. Conclusion: Assisted oocyte activation with calcium ionophore results in significant improvement in the fertilization, cleavage and pregnancy rates after ICSI.

Conditions

Infertility Primary

Outcome Measures

Primary Outcomes (1)

• fertilization rate

  the number of reproduced embryos divided by the number of fertilized oocytes

  one and half year for all patients

Secondary Outcomes (1)

• Pregnancy rate

  one and half year for all patients

Study Arms (2)

study group

ACTIVE COMPARATOR

. This group involved 75 patients with history of fertilization failure in which oocytes were activated by calcium ionophores

Drug: Calcium Ionophore A23187

control group

NO INTERVENTION

This group involved 75 patients with history of fertilization failure in which oocytes were not activated by calcium ionophores

Interventions

Calcium Ionophore A23187 DRUG

Calcium Ionophore A23187 is used in laboratories to increase intracellular Ca2+ levels in intact cells. It also uncouples oxidative phosphorylation, the process cells use to synthesize Adenosine triphosphate which they use for energy. In addition, A23187 inhibits mitochondrial ATPase activity. A23187 also induces apoptosis in some cells (e.g. mouse lymphoma cell line, or S49, and Jurkat cells) and prevents it in others (e.g. cells dependent on interleukin 3 that have had the factor withdrawn). In IVF field, Ca Ionophore can be used in case of low fertilization rate after ICSI procedure, particularly with Globozoospermia (Round Head sperm syndrome), Ca Ionophore will replace absence of sperm acrosom, and plays role in oocyte activation after ICSI. Recommended use is 0.5 microgram/ml twice for 10 min interrupted with fresh media with 30 min incubation, followed with regular injected eggs culture for IVF.

Also known as: non

study group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (1) Age between 20 and 40 years old. (2) Cases with history of total fertilization failure in previous ICSI cycles (3) Oocytes with normal morphology.

You may not qualify if:

• (1) Abnormal oocyte morphology degenerated or immature oocytes. (2) Husbands with spermatogenic arrest or Sertoli/Leydig cells only.

Sponsors & Collaborators

• MOHAMED BEHERY: lead

Study Sites (1)

Al-Azhar University

Cairo, Nasr City, 17151, Egypt

Location

Study Officials

• doaa DA aswad, Master

  specialist of obstetrics and gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Behery MA

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: July 15, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 17, 2018
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)