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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

ESRA NUR TOLA contact

+90 5327921084

perinatalog@hotmail.com

Turkey (Türkiye)2 sites, 2 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

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT03345030
Study groupRoleWhat they receive
Unexplained infertile groupPatients 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 groupThe 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted17 Nov 2017
  2. Study start9 May 2017
  3. Primary completion30 Jan 2018 (estimated)
  4. Study completion30 Mar 2018 (estimated)

Resources

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)
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 20658732

  • Ramzan 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 26281346

  • Gunasekarana 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

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; AzTrials last refreshed its copy on 8 Nov 2026.

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