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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05947526
Other study ID # 2023-10/349
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2023
Est. completion date December 10, 2023

Study information

Verified date July 2023
Source Acibadem University
Contact NAZLI ALBAYRAK, MD
Phone 00905054111626
Email albayraknalzi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, it is aimed to analyze the outcomes of embryos obtained from ovarian follicle with different sizes, and identify the microRNA expression in the spent media of the blastocysts cultures.


Description:

In this study, it is aimed to analyze the outcomes of embryos obtained from ovarian follicle with different sizes. By this way, we assume to predict which follicle is able to give the best blastocyst. After the blastocysts are obtained from the different sized follicles, blastocyst cultures are going to be studied for the up and down-regulations of microRNA, besides the correlation of embryo quality with miRNA expression in the spent media.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date December 10, 2023
Est. primary completion date October 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 38 Years
Eligibility Inclusion Criteria: - Female patients aged between 20-38 who are planned to have IVF treatment - On the day of trigger before the oocyte pick-up, patients having at least 5, and 14 at most follicles exceeding 11mm - Patient having BMI below 30 Exclusion Criteria: - PCO patients - Patients having endometriosis - Patients having male factor with severe oligoazoospermia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Oocyte pick-up
With the needle, transvaginally USG-guided oocyte pick-up procedure is going to be performed

Locations

Country Name City State
Turkey Acibadem University Atakent Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Annes K, Muller DB, Vilela JAP, Valente RS, Caetano DP, Cibin FWS, Milazzotto MP, Mesquita FS, Belaz KRA, Eberlin MN, Sudano MJ. Influence of follicle size on bovine oocyte lipid composition, follicular metabolic and stress markers, embryo development and blastocyst lipid content. Reprod Fertil Dev. 2019 Mar;31(3):462-472. doi: 10.1071/RD18109. — View Citation

Costermans NGJ, Soede NM, van Tricht F, Blokland M, Kemp B, Keijer J, Teerds KJ. Follicular fluid steroid profile in sows: relationship to follicle size and oocyte qualitydagger. Biol Reprod. 2020 Mar 13;102(3):740-749. doi: 10.1093/biolre/ioz217. — View Citation

Kasapoglu I, Orhan A, Aslan K, Sen E, Kaya A, Avci B, Uncu G. Are all antral follicles the same? Size of antral follicles as a key predictor for response to controlled ovarian stimulation. J Obstet Gynaecol. 2022 Apr;42(3):461-466. doi: 10.1080/01443615.2021.1910640. Epub 2021 Jun 22. — View Citation

Mohr-Sasson A, Orvieto R, Blumenfeld S, Axelrod M, Mor-Hadar D, Grin L, Aizer A, Haas J. The association between follicle size and oocyte development as a function of final follicular maturation triggering. Reprod Biomed Online. 2020 Jun;40(6):887-893. doi: 10.1016/j.rbmo.2020.02.005. Epub 2020 Feb 20. — View Citation

Orvieto R, Mohr-Sasson A, Aizer A, Nahum R, Blumenfeld S, Kirshenbaum M, Haas J. Do Follicles of Obese Patients Yield Competent Oocytes/Embryos? Gynecol Obstet Invest. 2020;85(3):290-294. doi: 10.1159/000508226. Epub 2020 Jun 2. — View Citation

Orvieto R, Mohr-Sasson A, Blumenfeld S, Nahum R, Aizer A, Haas J. Does a Large (>24 mm) Follicle Yield a Competent Oocyte/Embryo? Gynecol Obstet Invest. 2020;85(5):416-419. doi: 10.1159/000510876. Epub 2020 Sep 23. — View Citation

Rosen MP, Shen S, Dobson AT, Rinaudo PF, McCulloch CE, Cedars MI. A quantitative assessment of follicle size on oocyte developmental competence. Fertil Steril. 2008 Sep;90(3):684-90. doi: 10.1016/j.fertnstert.2007.02.011. Epub 2008 Feb 4. — View Citation

Saith RR, Srinivasan A, Michie D, Sargent IL. Relationships between the developmental potential of human in-vitro fertilization embryos and features describing the embryo, oocyte and follicle. Hum Reprod Update. 1998 Mar-Apr;4(2):121-34. doi: 10.1093/humupd/4.2.121. — View Citation

Shapiro BS, Rasouli MA, Verma K, Raman A, Garner FC, Aguirre M, Kaye L, Bedient C. The effect of ovarian follicle size on oocyte and embryology outcomes. Fertil Steril. 2022 Jun;117(6):1170-1176. doi: 10.1016/j.fertnstert.2022.02.017. Epub 2022 Mar 30. — View Citation

Wittmaack FM, Kreger DO, Blasco L, Tureck RW, Mastroianni L Jr, Lessey BA. Effect of follicular size on oocyte retrieval, fertilization, cleavage, and embryo quality in in vitro fertilization cycles: a 6-year data collection. Fertil Steril. 1994 Dec;62(6):1205-10. doi: 10.1016/s0015-0282(16)57186-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Oocyte grading Morphologic Oocyte grading will be analyzed right after the procedure due to different follicle sizes after each hyper stimulation process of the patients, when the follicle sizes are large enough to pick up which is roughly 10-15 days after the hyper stimulation has started
Primary Day-3 Embryo Grading Morphologic Day-3 embryo grading will be analyzed after the procedure due to different follicle sizes Three days after the intracytoplasminc sperm injection(ICSI) procedure
Primary Day-5 Embryo Grading Day-5 embryo grading(Gardner classification) will be analyzed after the procedure due to different follicle sizes 5 days after the intracytoplasminc sperm injection(ICSI) procedure
Primary beta hCG results of the transferred embryos Clinical pregnancy outcomes ten days after the embryo transfer
Secondary micro RNA expression in culture medium In the culture medium of blastocysts are going to be analyzed for microRNA levels that are expressed Culture mediums of day 5 embryos will be collected to be studied, after the last embryo is obtained and all will be studied at the end of the recruitment
See also
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Completed NCT03085433 - Sperm Selection by Microfluidic Separation Improves Embryo Quality N/A
Recruiting NCT04011319 - Group Culture May Affect Embryo Quality in Assisted Reproduction Technology N/A