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

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status: Not yet enrolling

Conditions: Granulosa Cells; DNA Damage

Study type: Observational

Funder types: Other

Identifiers

NCT05558046

07/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Low Ovarian Reserve

Description:

Patients diagnosed as low ovarian reserve were recruited to the study who have Antimüllerian Hormone level of 1 ng/ml or lower. Patients with low ovarian reserve were diagnosed after normal standard infertility evaluation according to the guideline of The Practice Committee of the American Society for Reproductive Medicine which consist of the assesment of spermiogram, ovulation, hysterosalpingogram and if indicated ovarian reserve tests and laparoscopy. Male infertility is an exclusion.

Unexplained Infertile (Control group)

Description:

Patients diagnosed as unexplained infertility (UI) were recruited to the study who have Antimüllerian Hormone level of 1.5 ng/ml or higher as a control group. UI was diagnosed after normal standard infertility evaluation according to the guideline of The Practice Committee of the American Society for Reproductive Medicine which consist of the assesment of spermiogram, ovulation, hysterosalpingogram and if indicated ovarian reserve tests and laparoscopy.