Evaluation of the Relationship Between Oxidative Stress and Human Reproduction

NCT05575739 | Unknown

• 1 other identifier: CallaIVF
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IVF; Pregnancy; Oxidative Stress; Fertility Disorders

Keywords

Oxidative Stress; In vitro fertilisation; Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

  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.

  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.

  Day 1 of ovarian stimulation

Study Arms (2)

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 )

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 )

Interventions

Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins ) DIAGNOSTIC_TEST

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.

Male factor; Other causes of infertility

Eligibility Criteria

• Age: 20 Years - 54 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Calla IVF Center: lead

Study Sites (1)

Calla Ivf

Oradea, Bihor County, Romania

RECRUITING

Study Officials

• Anca Huniadi

  CALLA IVF

  STUDY CHAIR

Central Study Contacts

Ioana Alexandra Zaha

CONTACT

+040722639827; drzahaioana@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 12, 2022
• Study Start: February 14, 2021
• Primary Completion: December 31, 2022
• Study Completion: February 14, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

RO (1)