Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI)

Endometriosis Clinical Trial

— ROS  

Official title:

Does Antioxidant Supplementation to Endometriotic Women Undergoing ICSI Could Alter Reactive Oxygen Species (ROS) Levels and Affect Pregnancy Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058212
• Other study ID #: antioxidants for endometriosis
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2014
• Last updated: February 7, 2014
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

ROS plays an essential role in the pathogenesis of many reproductive processes. High follicular fluid ROS levels are associated with negative IVF outcomes.

is plasma level of reactive oxygen species is affected by antioxidant treatment in endometriotic women?

Description:

Study design, size, duration: : prospective randomized controlled clinical trial 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . randomization was done by closed envelop single blind for patient Participants/materials, setting, methods: was done in the Egyptian centre for IVF from March 2013 to October 2013 . 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . all patients were subjected to plasma sample before start long protocol for induction and second on day of ovum pick up . embryo transfer was done according to embryo grading .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• patients with endometriosis

Exclusion Criteria:

patients with no endometriosis , not suitable for ICSI-

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• ascorbate 1000mg, vitamin E 400, zinc and selenium
anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) are given to half patients only before IVF , plasma level of ROS are detected before and on day of oocyte retrieval then correlated to pregnancy outcome

Locations

Country	Name	City	State
Egypt	egyption centre for IVF	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma reactive oxygen species affection by antioxidant treatment	measure before and 3months after antioxidant treatment	3 months	No
Secondary	clinical pregnancy rate	long protocol administration	2 months	No