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AzTrials

Embryo QualityNCT05947526

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

An observational study of Embryo Quality, run by Acibadem University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 38 years, women onlyHealthy volunteers can take part
Conditions the study is for
Embryo Quality
What is being tested?
Oocyte pick-up
Type of treatment
Surgery or procedure
How many people
55 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jun 2023to 10 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 38 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

NAZLI ALBAYRAK, MD contact

00905054111626

albayraknalzi@gmail.com

TURGUT AYDIN, MD contact

00905323722713

turgut.aydin@acibadem.com

Turkey (Türkiye)1 site, 1 recruiting

  • Acibadem University Atakent Hospital

    Istanbul, 34303

    NAZLI ALBAYRAK, MD, 00905054111626, albayraknazli@gmail.com

    TURGUT AYDIN, MD, 00905323722713, turgut.aydin@acibadem.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed 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.

Conditions
Embryo Quality
Being tested
Oocyte pick-up
Keywords
follicle size, micro RNA, blastocyst culture, embryo quality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oocyte pick-upProcedure or surgery

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

Study groups in NCT05947526
Study groupRoleWhat they receive
Women referring to infertility clinic for IVF treatmentWomen 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
Receives: Procedure: Oocyte pick-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oocyte grading

    Morphologic Oocyte grading will be analyzed right after the procedure due to different follicle sizes

    Measured: 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

  2. Day-3 Embryo Grading

    Morphologic Day-3 embryo grading will be analyzed after the procedure due to different follicle sizes

    Measured: Three days after the intracytoplasminc sperm injection(ICSI) procedure

  3. Day-5 Embryo Grading

    Day-5 embryo grading(Gardner classification) will be analyzed after the procedure due to different follicle sizes

    Measured: 5 days after the intracytoplasminc sperm injection(ICSI) procedure

  4. beta hCG results of the transferred embryos

    Clinical pregnancy outcomes

    Measured: ten days after the embryo transfer

Secondary outcomes (1)

  1. micro RNA expression in culture medium

    In the culture medium of blastocysts are going to be analyzed for microRNA levels that are expressed

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start20 Jun 2023
  3. Primary completion20 Oct 2023 (estimated)
  4. Study completion10 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05947526
Sponsor's protocol ID
2023-10/349
Status last verified
Jul 2023
First submitted
23 Nov 2022
Last updated
17 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD is not going to be shared with other researchers. All data is going to be known only by one researcher.

Publications

  • 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.

    PubMed 35367061

  • 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.

    PubMed 32389425

  • 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.

    PubMed 31786607

  • 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.

    PubMed 18249377

  • 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.

    PubMed 30282571

  • 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.

    PubMed 32966987

  • 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.

    PubMed 34155958

  • 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.

    PubMed 9683350

  • 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.

    PubMed 7957985

  • 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.

    PubMed 32485714

Questions about this trial

What is this clinical trial studying?

An observational study of Embryo Quality, run by Acibadem University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact NAZLI ALBAYRAK, MD (00905054111626, albayraknalzi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oocyte grading (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05947526, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.

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