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

NCT05947526 | Unknown

• 1 other identifier: 2023-10/349
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Embryo Quality

Keywords

follicle size; micro RNA; blastocyst culture; embryo quality

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• beta hCG results of the transferred embryos

  Clinical pregnancy outcomes

  ten days after the embryo transfer

Secondary Outcomes (1)

• micro RNA expression in culture medium

  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

Study Arms (1)

Women referring to infertility clinic for IVF treatment

Women who were referred to infertility clinic with complaint of not having baby go through IVF treatment, and having oocyte pick-up procedure with different sizes of ovarian follicles

Procedure: Oocyte pick-up

Interventions

Oocyte pick-up PROCEDURE

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

Women referring to infertility clinic for IVF treatment

Eligibility Criteria

• Age: 20 Years - 38 Years
• Gender Eligibility Details: Patients must be all female, since the study is based on embryos obtained from different ovarian follicle sizes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are going to be included to the study will be the patients of infertility clinic

You may qualify if:

• 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

You may not qualify if:

• PCO patients
• Patients having endometriosis
• Patients having male factor with severe oligoazoospermia

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University Atakent Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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.

  PMID: 35367061 BACKGROUND

• 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.

  PMID: 32389425 BACKGROUND

• 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.

  PMID: 31786607 BACKGROUND

• 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.

  PMID: 18249377 BACKGROUND

• 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.

  PMID: 30282571 BACKGROUND

• 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.

  PMID: 32966987 BACKGROUND

• 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.

  PMID: 34155958 BACKGROUND

• 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.

  PMID: 9683350 BACKGROUND

• 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.

  PMID: 7957985 BACKGROUND

• 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.

  PMID: 32485714 BACKGROUND

Study Officials

• NAZLI ALBAYRAK, MD

  Acıbadem University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NAZLI ALBAYRAK, MD

CONTACT

00905054111626; albayraknalzi@gmail.com

TURGUT AYDIN, MD

CONTACT

00905323722713; turgut.aydin@acibadem.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, MD

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: July 17, 2023
• Study Start: June 20, 2023
• Primary Completion: October 20, 2023
• Study Completion: December 10, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)