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

Cairo University (CU)

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium

Study type: Interventional

Funder types: Other

Identifiers

NCT02058212

antioxidants for endometriosis

Details and patient eligibility

About

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?

Full 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 .

Enrollment: 50 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients with endometriosis

Exclusion criteria

patients with no endometriosis , not suitable for ICSI-

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

no antioxidant , ROS , pregnancy outcome

Placebo Comparator group

Description:

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

Treatment:

Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium

antioxidant , ROS , pregnancy outcome

Active Comparator group

Description:

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

Treatment:

Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium