Outcomes of the Embryos of Different Ovarian Follicle Sizes, and the miRNA Detection in Their Blastocyst Culture

Embryo Quality Clinical Trial

Official title:

Evaluation of the Outcomes of the Embryos Obtained From Different Follicle Sizes, and the miRNA Detection in the Spent Media of Their Blastocyst Culture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947526
• Other study ID #: 2023-10/349
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Embryo Quality

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