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

Calla IVF Center

Status: Enrolling

Conditions: Fertility Disorders; IVF; Oxidative Stress; Pregnancy

Treatments: Diagnostic Test: Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins )

Study type: Observational

Funder types: Other

Identifiers

NCT05575739

CallaIVF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 20 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Male factor

Description:

Couples that have just the male factor as cause of infertility

Treatment:

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

Other causes of infertility

Description:

diminished ovarian reserve polycystic ovarian syndrome unexplained infertility tubal factor

Treatment:

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