DNA DamageNCT05558046
Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique
An observational study of DNA Damage and Granulosa Cells, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- DNA Damage, Granulosa Cells
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 20 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
- Endocrinopathy (Thyroid, prolactin... abnormalities)
- Chemotherapy or radiotherapy history
- Endometriosis
- Policystic ovary syndrome
- Male infetility
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- DNA Damage, Granulosa Cells
- Keywords
- Ovarian Reserve, Flow Cytometry, Sperm Injections, Intracytoplasmic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
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
Measured: 1 day after ICSI procedure
Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer
Positive human chorionic gonadotropin levels
Measured: 12 days after embryo transfer
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
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erman Çiftçi, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558046
- Sponsor's protocol ID
- 07/2022
- Status last verified
- Sep 2022
- First submitted
- 24 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique
- ClinicalTrials.gov ID
- NCT05558046
- Acronym / sponsor ID
- 07/2022
- Conditions
- DNA Damage, Granulosa Cells
- Keywords
- Ovarian Reserve, Flow Cytometry, Sperm Injections, Intracytoplasmic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
- Endocrinopathy (Thyroid, prolactin... abnormalities)
- Chemotherapy or radiotherapy history
- Endometriosis
- Policystic ovary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining the correlation of ovarian reserve and age factor with DNA Damage markers in granulosa cells.
Time frame: 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.
3 secondary outcomes
Fertilization defined as the presence of two pronuclei under light microscope one day after intracytoplasmic sperm injection procedure
Time frame: 1 day after ICSI procedure
Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer
Time frame: 12 days after embryo transfer
Clinical pregnancy will be defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of DNA Damage and Granulosa Cells, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erman Ciftci, MD (+905074422414, ermanciftci1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the correlation of ovarian reserve and age factor with DNA Damage markers in granulosa cells. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.