Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients

Study Overview
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Brief Summary
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The aim of the study is to determine serum oxidative stress status by ischemia modified albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control group. We also aim to reveal the association between serum levels of these factors and oocyte quality.

Detailed Description
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Patients included in this study were assisted reproductive technique (ART) patients with moderate and severe OHSS who were hospitalized for management Control patients are selected from patients without signs of OHSS All patients are administered luteal long protocol for controlled ovarian stimulation. Pituitary down-regulation with SC injection of GnRH agonist (GnRH-a) (1 mg/day; Lucrin, Abbott Laboratories, North Chicago, IL) that was started on day 21 of the previous menstrual cycle. Subcutaneous administration of recombinant hFSH (Gonal-F, Laboratories Serono S.A., Aubonne, Switzerland) at dosages from 150-225 IU/day is initiated on the second or third day of menstruation. When there are at least two or three follicles >17 mm in diameter, recombinant human chorionic gonadotropin (0.25 µgr ; Ovitrelle IM, Serono, Istanbul, Turkey) is applied subcutaneously 34-36 hours before oocyte retrieval. Serum samples are collected on day of HCG for study and control group patients. Serum levels of ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels. This is a case control study Statistical analyses will be performed using student t-test and fisher chi-square test. The correlations between the serums IMA, TAC, TOC, OSI, and MDA levels will be examined in all study groups using Spearman correlation analysis.

Official Title
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Serum Levels of IMA, TAC, TOS, OSI and MDA in Severe OHSS Patients Underwent Long Agonist Protocol Intracytoplasmic Sperm for Determining Oxidative Stress Status

Conditions
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Ovarian Hyperstimulation Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients in both groups are normoresponders or hyperresponders who will undergo assisted reproductive technology for male factor Exclusion Criteria: known inherited or acquired thrombophilia previous thromboembolism previous, current or planned anti-thrombotic treatment first degree relatives with known genetic thrombophilia systemic diseases smoking.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ovarian hyperstimulation patients<br>Moderate OHSS is defined as abdominal distension and discomfort, nausea with or without vomiting, ovarian enlargement (ovarian size of 8-12 cm) and ascites that revealed by ultrasonografic examination. Severe OHSS criteria is defined as ovarian enlargement, ascites with or without hydrothorax, haematocrit >45%, weight gain >2 kg, white blood cell count >15.000, oliguria, creatinine of 1.0-1.5, creatinine clearance of >50 ml/min, liver dysfunction. | |
| without ovarian hiperstimulation<br>Control group is composed of patients who underwent long luteal protocol but do not demonstrate symptoms of OHSS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change the levels of oxidative stress markers | Serum will be obtained for studiying ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian hyperstimulation, Oxidative Stress, IMA, OHSS, ICSI, long agonist protocol, TAC, TOS, OSI, MDA