Clinical trial NCT05558046: Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique
Official title: Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: DNA Damage
Granulosa Cells
Keywords: Ovarian Reserve
Flow Cytometry
Sperm Injections, Intracytoplasmic
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low ovarian reserve group will be included as Antimullerian hormone level results as lower than 1 ng/ml without any other infertility evidence.The control group received IVF for Unexplained infertile (UI) 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 as well as Antimullerian hormone level results as greater than 1,5 ng/ml. If the results of all this tests were normal, patients were accepted as UI.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determining the correlation of ovarian reserve and age factor with DNA Damage markers in granulosa cells.
timeFrame: 1 day
Secondary outcomes:
measure: Fertilization defined as the presence of two pronuclei under light microscope one day after intracytoplasmic sperm injection procedure
timeFrame: 1 day after ICSI procedure
measure: Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer
timeFrame: 12 days after embryo transfer
measure: Clinical pregnancy will be defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
References: