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The Role of DNA Damage of Granulosa Cell on Oocyte Quality and in Vitro Fertilization Outcome

NCT ID: NCT03345030

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-09

Study Completion Date

2018-03-30

Brief Summary

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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

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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

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in Vitro Fertilization

Keywords

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comet assay DNA damage granulosa IVF outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Unexplained infertile patients undergoing in vitro fertilization (IVF) treatment

Exclusion Criteria

1. Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
2. Endocrinopathy (Thyroid, prolactin... abnormalities)
3. Chemotherapy or radiotherapy history
4. Cigarette, alcohol, chronic medication use
5. Diminished ovarian reserve
6. Endometriosis
7. Having any medication use
8. History of any surgical procedure on ovaries and uterus
9. Smoking or alcohol consumption
10. Severe oligoasthenospermia
11. Tubal infertility associated with hydrosalpinx, severe pelvic adhesions, endometriosis or pelvic inflammatory disease
Minimum Eligible Age

19 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

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Esra Nur tola

Assisstant Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ESRA NUR TOLA

Role: PRINCIPAL_INVESTIGATOR

Suleyman Demirel Univercity, Medicine Faculty, Department of Gyneacology and Obstetrics

Locations

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Esra Nur Tola

Isparta, Cunur, Turkey (Türkiye)

Site Status RECRUITING

Suleyman Demirel University, Faculty of Medicine

Isparta, Cunur, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ESRA NUR TOLA

Role: CONTACT

Phone: +90 5327921084

Email: [email protected]

Facility Contacts

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ESRA NUR TOLA

Role: primary

ESRA NUR TOLA

Role: primary

References

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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.

Reference Type RESULT
PMID: 20658732 (View on PubMed)

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.

Reference Type RESULT
PMID: 26281346 (View on PubMed)

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.

Reference Type RESULT
PMID: 25954633 (View on PubMed)

Other Identifiers

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7286572.050.01-29906

Identifier Type: -

Identifier Source: org_study_id