NCT05558046

Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Deoxyribonucleic acid (DNA) damage of granulosa cells obtained during oocyte retrieval will be evaluated by flow cytometry with detection of Histone H2A.X and Phosphorylated Gamma H2A.X protein levels in patients with low ovarian reserve and unexplained infertile patients as a control group undergoing intracytoplasmic sperm injection (ICSI) treatment. Fertilization, embryo quality, transfer rate, implantation, clinical pregnancy will be recorded as well as demographic data. DNA damage of granulosa cells will be compared between two groups. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

Detailed description

Granulosa cells surrounding the oocytes will be mechanically obtained during the oocyte pick-up procedure in women undergoing intracytoplasmic sperm injection (ICSI) treatment due to unexplained infertility and low ovarian reserve. Deoxyribonucleic acid (DNA) damage in these cells will be evaluated by flow cytometry. Fertilization rates, embryo quality by grading, and transfer rates will also be assessed. Implantation and clinical pregnancy rates will be recorded as well as demographic data such as age, body-mass index, smoking, alcohol use, employment, coexisting chronic disease, infertility duration, etiology of infertility, treatment protocol. Implantation will be evaluated by determination of serum human chorionic gonadotropin (hCG) at day 15 following an embryo transfer. Clinical pregnancy will be diagnosed upon presence of gestational sac on ultrasound examination. DNA damage of granulosa cells will be compared between low ovarian reserve group and control group. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

Conditions

• DNA Damage
• Granulosa Cells

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-03-01
• Completion: 2023-06-20
• First posted: 2022-09-28
• Last updated: 2022-09-28