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

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05558046

Collaborator

(none)

Enrollment

8.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
DNA Damage Granulosa Cells

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Low Ovarian Reserve 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) 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.

Arm

Intervention/Treatment

Low Ovarian Reserve

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)

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.

Outcome Measures

Primary Outcome Measures

Determining the correlation of ovarian reserve and age factor with DNA Damage markers in granulosa cells. [1 day]
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.

Secondary Outcome Measures

Fertilization defined as the presence of two pronuclei under light microscope one day after intracytoplasmic sperm injection procedure [1 day after ICSI procedure]
Presence of two pronuclei under light microscope
Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer [12 days after embryo transfer]
Positive human chorionic gonadotropin levels
Clinical pregnancy will be defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer [5 weeks]
Presence of a gestational sac in transvaginal ultrasonographic examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erman Çiftçi, MD, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

ClinicalTrials.gov Identifier:

NCT05558046

Other Study ID Numbers:

07/2022

First Posted:

Sep 28, 2022

Last Update Posted:

Sep 28, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erman Çiftçi, MD, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Ovarian Reserve

Flow Cytometry

Sperm Injections, Intracytoplasmic

Study Results

No Results Posted as of Sep 28, 2022