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

NCT03345030 | Unknown

• 1 other identifier: 7286572.050.01-29906
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

in Vitro Fertilization

Keywords

comet assay; DNA damage; granulosa; IVF outcome

Outcome Measures

Primary Outcomes (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

  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

  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

  36 hours after human chorionic gonadotropin administration

• Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure

  3 days after intracytoplasmic sperm injection procedure

• Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer

  12 days after embryo transfer

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
• Endocrinopathy (Thyroid, prolactin... abnormalities)
• Chemotherapy or radiotherapy history
• Cigarette, alcohol, chronic medication use
• Diminished ovarian reserve
• Endometriosis
• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (2)

Esra Nur Tola

Isparta, Cunur, 32200, Turkey (Türkiye)

RECRUITING

Suleyman Demirel University, Faculty of Medicine

Isparta, Cunur, 32200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 20658732 RESULT

• 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.

  PMID: 26281346 RESULT

• 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.

  PMID: 25954633 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

granulosa cells (cumulus oophorus complex) surrounding the oocyte

Study Officials

• ESRA NUR TOLA

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ESRA NUR TOLA

CONTACT

+90 5327921084; perinatalog@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor Doctor

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 17, 2017
• Study Start: May 9, 2017
• Primary Completion: January 30, 2018
• Study Completion: March 30, 2018
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)