Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients
NCT ID: NCT02202278
Last Updated: 2014-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2014-06-30
2014-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ovarian hyperstimulation patients
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.
No interventions assigned to this group
without ovarian hiperstimulation
Control group is composed of patients who underwent long luteal protocol but do not demonstrate symptoms of OHSS
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* previous thromboembolism
* previous, current or planned anti-thrombotic treatment
* first degree relatives with known genetic thrombophilia
* systemic diseases
* smoking.
20 Years
40 Years
FEMALE
No
Sponsors
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Karadeniz Technical University
OTHER
Responsible Party
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emine seda guvendag guven
medical doctor
Principal Investigators
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emine seda guvendag guven, MD
Role: STUDY_DIRECTOR
Karadeniz Technical University
rafet duraker, MD
Role: PRINCIPAL_INVESTIGATOR
T. C Etlik Zubeyde Hanim Women's health Teaching Hospital
Locations
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T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Hitkari JA, Rowe TP, von Dadelszen P. Activated protein C and the ovarian hyperstimulation syndrome: possible therapeutic implications. Med Hypotheses. 2006;66(5):929-33. doi: 10.1016/j.mehy.2005.08.058. Epub 2006 Jan 24.
Westerlund E, Henriksson P, Wallen H, Hovatta O, Wallberg KR, Antovic A. Detection of a procoagulable state during controlled ovarian hyperstimulation for in vitro fertilization with global assays of haemostasis. Thromb Res. 2012 Oct;130(4):649-53. doi: 10.1016/j.thromres.2011.11.024. Epub 2011 Dec 7.
Agarwal A, Allamaneni SS. Role of free radicals in female reproductive diseases and assisted reproduction. Reprod Biomed Online. 2004 Sep;9(3):338-47. doi: 10.1016/s1472-6483(10)62151-7.
Velthut A, Zilmer M, Zilmer K, Kaart T, Karro H, Salumets A. Elevated blood plasma antioxidant status is favourable for achieving IVF/ICSI pregnancy. Reprod Biomed Online. 2013 Apr;26(4):345-52. doi: 10.1016/j.rbmo.2012.12.012. Epub 2013 Jan 16.
Other Identifiers
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139EK1
Identifier Type: -
Identifier Source: org_study_id
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