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

in Vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03345030
• Other study ID #: 7286572.050.01-29906
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2017
• Last updated: November 21, 2017
• Start date: May 9, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: November 2017
• Source: Suleyman Demirel University
• Contact: ESRA NUR TOLA
• Phone: +90 5327921084
• Email: perinatalog[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• in Vitro Fertilization

Locations

Country	Name	City	State
Turkey	Esra Nur Tola	Isparta	Cunur
Turkey	Suleyman Demirel University, Faculty of Medicine	Isparta	Cunur

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 day after intracytoplasmic sperm injection procedure
Secondary	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).	36 hours after human chorionic gonadotropin administration
Secondary	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.	3 days after intracytoplasmic sperm injection procedure
Secondary	Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer	Positive human chorionic gonadotropin levels	12 days after embryo transfer