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UnknownNCT05575739

Evaluation of the Relationship Between Oxidative Stress and Human Reproduction

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.

Status
Unknown
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Calla IVF Center · Academic / Other
Sex
Female
Age
20 Years – 54 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMeasurement 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.

Timeline

Start date
2021-02-14
Primary completion
2022-12-31
Completion
2023-02-14
First posted
2022-10-12
Last updated
2022-10-12

Locations

1 site across 1 country: Romania

Source: ClinicalTrials.gov record NCT05575739. Inclusion in this directory is not an endorsement.