in Vitro FertilizationNCT03345030
The Role of DNA Damage of Granulosa Cell on Oocyte Quality and in Vitro Fertilization Outcome
An observational study of in Vitro Fertilization, run by Suleyman Demirel University at 2 sites in Turkey (Türkiye).
Trial summary
Deoxyribonucleic acid (DNA) damage of granulosa cells obtained during oocyte retrieval will be evaluated by comet assay in unexplained infertile patients undergoing in vitro fertilization (IVF) treatment. The oocytes will be graded by particular criteria. Read more about this study
- Who is it for?
- Ages 19 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- in Vitro Fertilization
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 9 May 2017to 30 Mar 2018
- 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 19 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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. If the results of all this tests were normal, patients were accepted as UI. Control group The control group received IVF for male infertility (except azoospermia and severe oligoasthenospermia) or tubal factor included only those women who had salpingectomy for ectopic pregnancy.
Who may be able to join
- Unexplained infertile patients undergoing in vitro fertilization (IVF) treatment
Who cannot join
- Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
- Endocrinopathy (Thyroid, prolactin... abnormalities)
- Chemotherapy or radiotherapy history
- Cigarette, alcohol, chronic medication use
- Diminished ovarian reserve
- Endometriosis
Show all 11Show fewer
- Having any medication use
- History of any surgical procedure on ovaries and uterus
- Smoking or alcohol consumption
- Severe oligoasthenospermia
- Tubal infertility associated with hydrosalpinx, severe pelvic adhesions, endometriosis or pelvic inflammatory disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Esra Nur Tola
Isparta, Cunur, 32200
ESRA NUR TOLA, +90 5327921084, perinatalog@hotmail.com
- Recruiting
Suleyman Demirel University, Faculty of Medicine
Isparta, Cunur, 32200
ESRA NUR TOLA, 5329721084, perinatalog@hotmail.com
About this study
Deoxyribonucleic acid (DNA) damage of granulosa cells obtained during oocyte retrieval will be evaluated by comet assay in unexplained infertile patients undergoing in vitro fertilization (IVF) treatment. The oocytes will be graded by particular criteria. Fertilization, embryo quality, transfer rate, implantation, clinical pregnancy, pregnancy outcomes (gestational age at delivery, route of delivery, and birthweight etc.) will be recorded as well as demographic data. DNA damage of granulosa cells will be compared between unexplained infertile and control 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 in vitro fertilization (IVF) treatment due to unexplained infertility. Deoxyribonucleic acid (DNA) damage in these cells will be evaluated by comet assay. The quality of oocytes retrieved during the oocyte pick-up procedure will be graded by particular criteria (zona pellucida thickness, granulation, vacuolization, etc). Fertilization rates, embryo quality by grading, and transfer rates will also be assessed. Implantation and clinical pregnancy rates, and pregnancy outcomes including gestational age at delivery, route of delivery, and birthweight 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, and hormone levels on day 3. Implantation will be evaluated by determination of serum human chorionic gonadotropin (hCG) at day 12 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 unexplained infertile 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
- in Vitro Fertilization
- Keywords
- comet assay, DNA damage, granulosa, IVF outcome
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 |
|---|---|---|
| Unexplained infertile group | Patients diagnosed as unexplained infertility (UI) were recruited to the study. 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. If the results of all this tests were normal, patients were accepted as UI. | |
| Control group | The control group received in vitro fertilization (IVF) for tubal factor and included only those women who had salpingectomy for ectopic pregnancy or proximal tubal obstruction because of low-grade infection or fimbrial occlusion with or without mild peritubal adhesions. Tubal infertility associated with hydrosalpinx, severe pelvic adhesions, endometriosis or pelvic inflammatory disease were excluded. Patients with male factor except oligoasthenospermia were also recruited for the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy 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 after embryo transfer
Secondary outcomes (4)
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 intracytoplasmic sperm injection procedure
Oocyte grade assessed by four parameters (cytoplasmic granulation, properties of the polar body, the perivitelline space and properties of the zona pellucida) under invert microscope 36 hours after human chorionic gonadotropin administration
Oocytes were graded by particular criteria including cytoplasmic granulation, properties of polar body, perivitellin space and zona pellucida. Central cytoplasmic granulation=0, homogenous cytoplasmic granulation=1; large fragmented polar bodies=0, non-fragmented polar bodies with normal size=1; presence of debris in perivitellin space=0, absence of debris in perivitelline space=1; >15 mm thickness and rough surfaced zona pellucida=0, <15 mm thickness and smooth surface zona pellucida=1. A total of used 3-4 points were considered as Grade 1 oocytes (best quality), 2-3 points were grade 2 (moderate quality), 0-1 points were considered as grade 3 (poor quality).
Measured: 36 hours after human chorionic gonadotropin administration
Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure
The quality of embryos was graded from 1 to 3 under inverted microscope 3 days after intracytoplasmic sperm injection procedure. Embryos with even-sized blastomers and/or <5% fragments were classified as Grade 1 (good quality). Grade 2 embryos (moderate quality) had blastomeres with slightly-moderate size differences and/or 5-50% fragments. Grade 3 embryos (poor quality) had markedly different-sized blastomers and/or >50% fragments.
Measured: 3 days after intracytoplasmic sperm injection 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start9 May 2017
- Primary completion30 Jan 2018 (estimated)
- Study completion30 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for in Vitro FertilizationStudies 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
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Nur tola, Suleyman Demirel University
- Investigators
- ESRA NUR TOLA, Principal investigator, Suleyman Demirel Univercity, Medicine Faculty, Department of Gyneacology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345030
- Sponsor's protocol ID
- 7286572.050.01-29906
- Status last verified
- Nov 2017
- First submitted
- 3 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nersesyan A, Chobanyan N. Micronuclei and other nuclear anomalies levels in exfoliated buccal cells and DNA damage in leukocytes of patients with polycystic ovary syndrome. J BUON. 2010 Apr-Jun;15(2):337-9.
PubMed 20658732Ramzan MH, Ramzan M, Khan MM, Ramzan F, Wahab F, Khan MA, Jillani M, Shah M. Human semen quality and sperm DNA damage assessed by comet assay in clinical groups. Turk J Med Sci. 2015;45(3):729-37. doi: 10.3906/sag-1407-50.
PubMed 26281346Gunasekarana V, Raj GV, Chand P. A comprehensive review on clinical applications of comet assay. J Clin Diagn Res. 2015 Mar;9(3):GE01-5. doi: 10.7860/JCDR/2015/12062.5622. Epub 2015 Mar 1.
PubMed 25954633
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of DNA Damage of Granulosa Cell on Oocyte Quality and in Vitro Fertilization Outcome
- ClinicalTrials.gov ID
- NCT03345030
- Acronym / sponsor ID
- 7286572.050.01-29906
- Conditions
- in Vitro Fertilization
- Keywords
- comet assay, DNA damage, granulosa, IVF outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 30 Jan 2018 (estimated)
- Study completion
- 30 Mar 2018 (estimated)
- First posted
- 17 Nov 2017 (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 comet assay in unexplained infertile patients undergoing in vitro fertilization (IVF) treatment. The oocytes will be graded by particular criteria. Fertilization, embryo quality, transfer rate, implantation, clinical pregnancy, pregnancy outcomes (gestational age at delivery, route of delivery, and birthweight etc.) will be recorded as well as demographic data. DNA damage of granulosa cells will be compared between unexplained infertile and control 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 in vitro fertilization (IVF) treatment due to unexplained infertility. Deoxyribonucleic acid (DNA) damage in these cells will be evaluated by comet assay. The quality of oocytes retrieved during the oocyte pick-up procedure will be graded by particular criteria (zona pellucida thickness, granulation, vacuolization, etc). Fertilization rates, embryo quality by grading, and transfer rates will also be assessed. Implantation and clinical pregnancy rates, and pregnancy outcomes including gestational age at delivery, route of delivery, and birthweight 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, and hormone levels on day 3. Implantation will be evaluated by determination of serum human chorionic gonadotropin (hCG) at day 12 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 unexplained infertile 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 |
|---|---|---|
| Unexplained infertile group | – | –Patients diagnosed as unexplained infertility (UI) were recruited to the study. 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. If the results of all this tests were normal, patients were accepted as UI. |
| Control group | – | –The control group received in vitro fertilization (IVF) for tubal factor and included only those women who had salpingectomy for ectopic pregnancy or proximal tubal obstruction because of low-grade infection or fimbrial occlusion with or without mild peritubal adhesions. Tubal infertility associated with hydrosalpinx, severe pelvic adhesions, endometriosis or pelvic inflammatory disease were excluded. Patients with male factor except oligoasthenospermia were also recruited for the study. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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. If the results of all this tests were normal, patients were accepted as UI. Control group The control group received IVF for male infertility (except azoospermia and severe oligoasthenospermia) or tubal factor included only those women who had salpingectomy for ectopic pregnancy.
Key inclusion criteria (1 listed)
- Unexplained infertile patients undergoing in vitro fertilization (IVF) treatment
Key exclusion criteria (11 listed)
- Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
- Endocrinopathy (Thyroid, prolactin... abnormalities)
- Chemotherapy or radiotherapy history
- Cigarette, alcohol, chronic medication use
- Diminished ovarian reserve
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
Clinical pregnancy defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer
Time frame: 5 weeks after embryo transfer
Presence of a gestational sac in transvaginal ultrasonographic examination
4 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 intracytoplasmic sperm injection procedure
Oocyte grade assessed by four parameters (cytoplasmic granulation, properties of the polar body, the perivitelline space and properties of the zona pellucida) under invert microscope 36 hours after human chorionic gonadotropin administration
Time frame: 36 hours after human chorionic gonadotropin administration
Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure
Time frame: 3 days after intracytoplasmic sperm injection procedure
Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer
Time frame: 12 days after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Results publication: PubMed 20658732Nersesyan A, Chobanyan N. Micronuclei and other nuclear anomalies levels in exfoliated buccal cells and DNA damage in leukocytes of patients with polycystic ovary syndrome. J BUON. 2010 Apr-Jun;15(2):337-9.
- Results publication: PubMed 26281346Ramzan MH, Ramzan M, Khan MM, Ramzan F, Wahab F, Khan MA, Jillani M, Shah M. Human semen quality and sperm DNA damage assessed by comet assay in clinical groups. Turk J Med Sci. 2015;45(3):729-37. doi: 10.3906/sag-1407-50.
- Results publication: PubMed 25954633Gunasekarana V, Raj GV, Chand P. A comprehensive review on clinical applications of comet assay. J Clin Diagn Res. 2015 Mar;9(3):GE01-5. doi: 10.7860/JCDR/2015/12062.5622. Epub 2015 Mar 1.
- Individual participant dataSharing planned: No
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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.
ESRA NUR TOLA principal investigator
Suleyman Demirel Univercity, Medicine Faculty, Department of Gyneacology and Obstetrics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of in Vitro Fertilization, run by Suleyman Demirel University at 2 sites in Turkey (Türkiye).
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 1 inclusion and 11 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 ESRA NUR TOLA (+90 5327921084, perinatalog@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer (time frame: 5 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345030, which also lists 3 linked publications.
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 24 Nov 2017.