DNA Damage Clinical Trial
Official title:
Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | June 20, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - For patients who are undergoing in Vitro Fertilization (IVF) treatment with Low ovarian reserve, Antimullerian Hormone level must be lower than 1 ng/mL - For patients who are undergoing in Vitro Fertilization (IVF) treatment with Unexplained infetility, Antimullerian Hormone level must be greater than 1,5 ng/mL Exclusion Criteria: - Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..) - Endocrinopathy (Thyroid, prolactin... abnormalities) - Chemotherapy or radiotherapy history - Endometriosis - Policystic ovary syndrome - Male infetility |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Zeynep Kamil Maternity and Pediatric Research and Training Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determining the correlation of ovarian reserve and age factor with DNA Damage markers in granulosa cells. | Demographic data will be noted for each patient at the day of oocyte retrieval, and DNA damage markers will be shown by flowcytometry at the same day. | 1 day | |
Secondary | Fertilization defined as the presence of two pronuclei under light microscope one day after intracytoplasmic sperm injection procedure | Presence of two pronuclei under light microscope | 1 day after ICSI procedure | |
Secondary | Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer | Positive human chorionic gonadotropin levels | 12 days after embryo transfer | |
Secondary | Clinical pregnancy will be defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer | Presence of a gestational sac in transvaginal ultrasonographic examination | 5 weeks |
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