Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst?
NCT ID: NCT05837325
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-05-23
2026-12-31
Brief Summary
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Detailed Description
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To have complete information between the serum hormones, follicular hormones, embryo development and ploidy will provide to clinicians, embryologist and patients further information on embryo selection and adequate ovarian stimulation protocols.
The database will be exported from the clinical information manager, VRepro, to a table in excel format through a database-based query system. The exported data will be duly codified to protect the clinical and personal information of the participants. Prior to the statistical study, an exploratory data analysis will be carried out to review the quality of the information extracted.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study Group
ICSI
One oocyte injected at a time.
Culture
One embryo per culture drop. Individual follow-up of the embryo development.
Biopsy
One embryo per culture drop.
Vitrification
One embryo per vitrification straw.
OPU - Study Group
Measure the size of the follicle and aspirate only one follicle and flush. The needle before moving to the second ovary. Oocyte included in the study will be cultured separately (each ovary separately too).
Denudation - Study Group
Oocyte included in the study will be denuded separately. Maturational stages are recorded per follicle.
Out of Study Group
Oocyte Pick Up - Out of Study
Aspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish.
Denudation - Out of Study
All oocytes are denuded together. Maturational stages are recorded.
ICSI
One oocyte injected at a time.
Culture
One embryo per culture drop. Individual follow-up of the embryo development.
Biopsy
One embryo per culture drop.
Vitrification
One embryo per vitrification straw.
Interventions
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Oocyte Pick Up - Out of Study
Aspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish.
Denudation - Out of Study
All oocytes are denuded together. Maturational stages are recorded.
ICSI
One oocyte injected at a time.
Culture
One embryo per culture drop. Individual follow-up of the embryo development.
Biopsy
One embryo per culture drop.
Vitrification
One embryo per vitrification straw.
OPU - Study Group
Measure the size of the follicle and aspirate only one follicle and flush. The needle before moving to the second ovary. Oocyte included in the study will be cultured separately (each ovary separately too).
Denudation - Study Group
Oocyte included in the study will be denuded separately. Maturational stages are recorded per follicle.
Eligibility Criteria
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Inclusion Criteria
* Age from 18 to 40 years old
* Normal menstrual cycle of 25-35 days
* Poor, normal and high response will be included
* First follicle punctured from each ovary will be consider for inclusion: if the COC (Cumulus Oocyte Complex) is present in clear FF (Follicular fluid), the FF will be collected separately for further analysis and the oocyte included in the study
Exclusion Criteria
* If the COC is not found in the follicular fluid
* Azoospermia
* Known chromosomal abnormalities
* Severe OAT (Oligoasthenoteratozoospermia)
18 Years
40 Years
FEMALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Laura Melado
Principal Investigator
Principal Investigators
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Laura Melado, PhD
Role: PRINCIPAL_INVESTIGATOR
ART Fertility Clinics LLC
Locations
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ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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References
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Hattori Y, Sato T, Okada H, Saito C, Sugiura-Ogasawara M. Comparison of follicular fluid and serum anti-Mullerian hormone levels as predictors of the outcome of assisted reproductive treatment. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):252-6. doi: 10.1016/j.ejogrb.2013.03.021. Epub 2013 Apr 25.
Capkin SI, Ozyer S, Karayalcin R, Moraloglu O, Ozcan S, Ugur M. Serum and follicular fluid Anti-Mullerian hormone concentrations at the time of follicle puncture and reproductive outcome. J Turk Ger Gynecol Assoc. 2012 Mar 1;13(1):21-6. doi: 10.5152/jtgga.2011.71. eCollection 2012.
Melado Vidales L, Fernandez-Nistal A, Martinez Fernandez V, Verdu Merino V, Bruna Catalan I, Bajo Arenas JM. Anti-Mullerian hormone levels to predict oocyte maturity and embryo quality during controlled ovarian hyperstimulation. Minerva Ginecol. 2017 Jun;69(3):225-232. doi: 10.23736/S0026-4784.16.03958-7. Epub 2016 Jun 28.
Hammoud I, Vialard F, Bergere M, Albert M, Gomes DM, Adler M, Malagrida L, Bailly M, Wainer R, Selva J. Follicular fluid protein content (FSH, LH, PG4, E2 and AMH) and polar body aneuploidy. J Assist Reprod Genet. 2012 Oct;29(10):1123-34. doi: 10.1007/s10815-012-9841-8. Epub 2012 Aug 14.
Calzada M, Lopez N, Noguera JA, Mendiola J, Hernandez AI, Corbalan S, Sanchez M, Torres AM. AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome. J Obstet Gynaecol. 2019 Nov;39(8):1130-1136. doi: 10.1080/01443615.2019.1587604. Epub 2019 Jun 17.
Devroey P, Aboulghar M, Garcia-Velasco J, Griesinger G, Humaidan P, Kolibianakis E, Ledger W, Tomas C, Fauser BC. Improving the patient's experience of IVF/ICSI: a proposal for an ovarian stimulation protocol with GnRH antagonist co-treatment. Hum Reprod. 2009 Apr;24(4):764-74. doi: 10.1093/humrep/den468. Epub 2009 Jan 19.
Ferraretti AP, Gianaroli L. The Bologna criteria for the definition of poor ovarian responders: is there a need for revision? Hum Reprod. 2014 Sep;29(9):1842-5. doi: 10.1093/humrep/deu139. Epub 2014 Jul 9.
Other Identifiers
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2212-ABU-015-LM
Identifier Type: -
Identifier Source: org_study_id
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