Evaluation of the Relationship Between Oxidative Stress and Human Reproduction (OxidStressHR)

Evaluation of the Relationship Between the Psychological Level of Stress, Serum Oxidative Stress, Follicular Fluid Oxidative Stress, Ovarian Hormones and Response to Gonadotropin Stimulation During IVF (in Vitro Fertilisation) Procedures.

The aim of the study is to investigate the role of oxidative stress in female infertility and the relationship between the stress as it is illustrated by questionnaires, serum markers, follicular fluid markers, and ovarian response in assisted reproduction.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Oxidative Stress; Fertility Disorders; IVF
• Intervention / Treatment: Diagnostic test: Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins )

Detailed Description

The investigators included patients that underwent an in vitro fertilization procedure in CALLA IVF Clinic.

All the patients had at least one ovarian stimulation cycle. In day two of the menstrual cycle the patients had a blood test for serum FSH(follicular stimulant hormone) E2 (estradiol) LH(Luteinizing hormone) and P(progesterone) as well as an ultrasound to asses the antral follicular count(AFC). The same day(day 2) the stimulation protocol begins. These four parameters are tested few times during the stimulation. The average stimulation protocol is 11 days. When the serum levels of hormones and ultrasound measurements of follicles reach the needed values (E2>1000pg/mL and follicles over 17mm) the hCG trigger is received. Transvaginal ultrasound guided oocyte retrieval was performed at 34-36 hours later. ICSI (intracitoplasmatic sperm injection) was performed and the fertilization by the presence of two pronuclei was confirmed 16-20 hours after the injection.

Follicular fluid and serum were obtained within 1 hour of oocyte recovery. Considerable care was taken to pool follicular fluid uncontaminated with blood. The samples were processed by centrifuge and 1-mL aliquots stored ar -80ºC until assay. Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins were measured from follicular fluid and plasma according to manufacturer's protocol. This assay has been described as highly sensitive. Data were expressed as millimoles per liter from the reference curve.

The parameters that are being observed are: number of oocytes, fertilisation rate and number of embryos.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Ioana Alexandra Zaha; Phone Number: +040722639827; Email: drzahaioana@gmail.com

Study Locations

• Romania
  • Bihor
    • Oradea, Bihor, Romania
      • Recruiting
      • Calla Ivf
      • Contact: Anca Huniadi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Population is homogeneous. Study group are females that struggle with infertility.

Description

Inclusion Criteria:

• all patients with the Infertility diagnosis (trying to conceive for over 12 months having regular unprotected sexual intercourse) and having an ovarian puncture during an IVF procedure

Exclusion Criteria:

• patients that need sperm and egg donors
• patients that refuse being enrolled in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Male factor; Couples that have just the male factor as cause of infertility	Diagnostic test: Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins ); Follicular fluid and serum were obtained within 1 hour of oocyte recovery. Considerable care was taken to pool follicular fluid uncontaminated with blood. The samples were processed by centrifuge and 1-mL aliquots stored ar -80ºC until assay. Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins were measured from follicular fluid and plasma according to manufacturer's protocol. This assay has been described as highly sensitive. Data were expressed as millimoles per liter from the reference curve.
Other causes of infertility; diminished ovarian reserve polycystic ovarian syndrome unexplained infertility tubal factor	Diagnostic test: Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins ); Follicular fluid and serum were obtained within 1 hour of oocyte recovery. Considerable care was taken to pool follicular fluid uncontaminated with blood. The samples were processed by centrifuge and 1-mL aliquots stored ar -80ºC until assay. Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins were measured from follicular fluid and plasma according to manufacturer's protocol. This assay has been described as highly sensitive. Data were expressed as millimoles per liter from the reference curve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follicular fluid and serum: malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins on the day of ovarian puncture in in vitro fertilisation procedures.	The primary outcome of the study is to establish the correlation between the oxidative stress markers and the ovarian response and the IVF(in vitro fertilization) success (number of oocytes retrieved, mature oocytes, fertilization rate, blastulation rate).	7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)
Correlation between the levels of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) and the cause of infertility.	The values of malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins in patients going trough an IVF procedure and the way the are associated with the cause of infertility. If the values differ between the two groups and if they impact the outcome of the IVF procedure (number of oocytes retrieved, mature oocytes, fertilization rate, blastulation rate) in either group.	7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire of psychological evaluation of perception of the day to day level of stress and the association with the levels of oxidative stress in the day of ovarian puncture.	Perceived stress questionnaire - having 3 levels of stress according to the points in each question.	1-2 hours
Correlation between maternal age and ovarian reserve and the values of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) in the ovarian stimulation outcome.	The values of antimullerian hormone in ng/mL and the values of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) and the succes rate of the IVF procedure.	18 months
Correlation between HOMA-IR value (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5), insulino-resistance and the body mass index, values of oxidative stress markers and ovarian stimulation outcome.	HOMA-IR value and body mass index in patients during the cycle of ovarian stimulation for IVF procedure.	Day 1 of ovarian stimulation

Collaborators and Investigators

• Sponsor: Calla IVF Center
• Investigators: Study Chair: Anca Huniadi, Calla Ivf

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): February 14, 2023

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 8, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Oxidative Stress; In vitro fertilisation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Free Radical Scavengers; Antioxidants; Superoxide Dismutase
• Other Study ID Numbers: CallaIVF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No