Clinical trial NCT05575739: Evaluation of the Relationship Between Oxidative Stress and Human Reproduction
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IVF
Pregnancy
Oxidative Stress
Fertility Disorders
Keywords: Oxidative Stress
In vitro fertilisation
Pregnancy
Lead sponsor: Calla IVF Center
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population is homogeneous. Study group are females that struggle with infertility.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)
measure: Correlation between the levels of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) and the cause of infertility.
timeFrame: 7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)
Secondary outcomes:
measure: 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.
timeFrame: 1-2 hours
measure: 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.
timeFrame: 18 months
measure: 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.
timeFrame: Day 1 of ovarian stimulation
Other outcomes:
Locations:
city: Oradea
country: Romania
facility: Calla Ivf
state: Bihor
Study officials:
affiliation: CALLA IVF
name: Anca Huniadi
role: STUDY_CHAIR
References: