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

DNA Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05558046
• Other study ID #: 07/2022
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: September 2022
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: Erman Ciftci, MD
• Phone: +905074422414
• Email: ermanciftci1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• DNA Damage
• Granulosa Cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Outcome

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