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

NCT ID: NCT02058212

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

Brief 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?

Detailed 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 .

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

no antioxidant , ROS , pregnancy outcome

no anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) will be given to endometriotic women undergoing IVF

Group Type: PLACEBO_COMPARATOR

ascorbate 1000mg, vitamin E 400, zinc and selenium

Intervention Type: DRUG

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

antioxidant , ROS , pregnancy outcome

anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium)

Group Type: ACTIVE_COMPARATOR

ascorbate 1000mg, vitamin E 400, zinc and selenium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients with endometriosis

Exclusion Criteria

patients with no endometriosis , not suitable for ICSI-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

olfat nouh riad

assisstant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

olfat nouh riad, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

egyption centre for IVF

Maadi, , Egypt

Maadi, , Egypt

Maadi, , Egypt

Countries

Egypt

Other Identifiers

antioxidants for endometriosis

Identifier Type: -

Identifier Source: org_study_id