Clinical trial NCT02202278: Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients
Official title: Serum Levels of IMA, TAC, TOS, OSI and MDA in Severe OHSS Patients Underwent Long Agonist Protocol Intracytoplasmic Sperm for Determining Oxidative Stress Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: ovarian hyperstimulation
Oxidative Stress
IMA
OHSS
ICSI
long agonist protocol
TAC
TOS
OSI
MDA
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are administered luteal long protocol for controlled ovarian stimulation

Brief summary: 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: * 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change the levels of oxidative stress markers
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital
Study officials:
affiliation: Karadeniz Technical University
name: emine seda guvendag guven, MD
role: STUDY_DIRECTOR
affiliation: T. C Etlik Zubeyde Hanim Women's health Teaching Hospital
name: rafet duraker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.