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).
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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University Atakent Hospital
Istanbul, 34303
NAZLI ALBAYRAK, MD, 00905054111626, albayraknazli@gmail.com
TURGUT AYDIN, MD, 00905323722713, turgut.aydin@acibadem.com
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Oocyte pick-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
beta hCG results of the transferred embryos
Clinical pregnancy outcomes
Measured: ten days after the embryo transfer
Secondary outcomes (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.
- First posted17 Jul 2023
- Study start20 Jun 2023
- Primary completion20 Oct 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Embryo QualityStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Albayrak, Acibadem University
- Investigators
- NAZLI ALBAYRAK, MD, Principal investigator, Acıbadem University School of Medicine
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 35367061Mohr-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 32389425Costermans 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 31786607Rosen 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 18249377Annes 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 30282571Orvieto 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 32966987Kasapoglu 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 34155958Saith 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 9683350Wittmaack 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 7957985Orvieto 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05947526
- Acronym / sponsor ID
- 2023-10/349
- Conditions
- Embryo Quality
- Keywords
- follicle size, micro RNA, blastocyst culture, embryo quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women referring to infertility clinic for IVF treatment | – | Procedure: Oocyte pick-upWomen 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 |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who are going to be included to the study will be the patients of infertility clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- PCO patients
- Patients having endometriosis
- Patients having male factor with severe oligoazoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oocyte pick-upWith the needle, transvaginally USG-guided oocyte pick-up procedure is going to be performed | Procedure or surgery | Women referring to infertility clinic for IVF treatment |
Primary outcome
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
Morphologic Oocyte grading will be analyzed right after the procedure due to different follicle sizes
Day-3 Embryo Grading
Time frame: Three days after the intracytoplasminc sperm injection(ICSI) procedure
Morphologic Day-3 embryo grading will be analyzed after the procedure due to different follicle sizes
Day-5 Embryo Grading
Time frame: 5 days after the intracytoplasminc sperm injection(ICSI) procedure
Day-5 embryo grading(Gardner classification) will be analyzed after the procedure due to different follicle sizes
beta hCG results of the transferred embryos
Time frame: ten days after the embryo transfer
Clinical pregnancy outcomes
1 secondary outcome
micro RNA expression in culture medium
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Background: PubMed 35367061Shapiro 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.
- Background: PubMed 32389425Mohr-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.
- Background: PubMed 31786607Costermans 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.
- Background: PubMed 18249377Rosen 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.
- Background: PubMed 30282571Annes 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.
- Background: PubMed 32966987Orvieto 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.
- Background: PubMed 34155958Kasapoglu 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.
- Background: PubMed 9683350Saith 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.
- Background: PubMed 7957985Wittmaack 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.
- Background: PubMed 32485714Orvieto 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.
- Individual participant dataSharing planned: No. IPD is not going to be shared with other researchers. All data is going to be known only by one researcher.
Related trials for Embryo Quality
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Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles
Embryo Culture, Embryo Culture Media
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Noninvasive Implantation Potential vs Morphology-Based Selection in IVF Single Blastocyst Transfer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NAZLI ALBAYRAK, MD principal investigator
Acıbadem University School of Medicine
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.