Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst?

Официальное название

Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst? A Prospective Study

Обзор

To investigate, whether on the day of egg retrieval, after ovarian stimulation for ICSI (intracytoplasmic sperm injection), there is a correlation between the intrafollicular AMH (Anti-Müllerian hormone) levels and the ploidy status of the blastocyst.

Подробное описание

In clinical practice, AMH is used as a diagnostic and/or prognostic marker in women in association with ovulation induction and in various pathophysiological conditions. This study looks to investigate if the hormonal environment that surrounds an oocyte has an impact on the ploidy status of the blastocyst. Nowadays, using NGS (Next Generation Sequencing) platform for analysis of 23 pairs of chromosomes for Preimplantation Genetic Testing on blastocysts, the ploidy status of the embryo is more adequately assessed. Furthermore, embryo culture to blastocyst will provide further information about embryo quality and possibilities of implantation.

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.

Вмешательства

• Процедура Oocyte Pick Up - Out of Study
  Aspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish.
• Процедура Denudation - Out of Study
  All oocytes are denuded together. Maturational stages are recorded.
• Процедура ICSI
  One oocyte injected at a time.
• Процедура Culture
  One embryo per culture drop. Individual follow-up of the embryo development.
• Генная терапия Biopsy
  One embryo per culture drop.
• Процедура Vitrification
  One embryo per vitrification straw.
• Процедура 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).
• Процедура Denudation - Study Group
  Oocyte included in the study will be denuded separately. Maturational stages are recorded per follicle.

Первичные конечные точки

• Oocyte maturity [Срок оценки: 1 day]
• Fertilization [Срок оценки: 1 day]
• Blastulation [Срок оценки: 1 day]
• Blastocyst quality [Срок оценки: 6 days]
• Ploidy status [Срок оценки: 14 days]
• Mitochondria status [Срок оценки: 14 days]

Вторичные конечные точки (12)

• AMH in the follicular fluid. [Срок оценки: 1 day]
• FSH in the follicular fluid. [Срок оценки: 1 day]
• LH in the follicular fluid. [Срок оценки: 1 day]
• E2 in the follicular fluid. [Срок оценки: 1 day]
• P4 in the follicular fluid. [Срок оценки: 1 day]
• Inhibin B in the follicular fluid. [Срок оценки: 1 day]
• AMH in serum day of OPU [Срок оценки: 1 day]
• FSH in serum day of OPU [Срок оценки: 1 day]
• LH in serum day of OPU [Срок оценки: 1 day]
• E2 in serum day of OPU [Срок оценки: 1 day]
• P4 in serum day of OPU [Срок оценки: 1 day]
• Inhibin B in serum day of OPU [Срок оценки: 1 day]

Критерии участия

Критерии включения

• At least one follicle from each ovary at day of trigger
• 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

Критерии исключения

• Very hematic follicular fluid
• If the COC is not found in the follicular fluid
• Azoospermia
• Known chromosomal abnormalities
• Severe OAT (Oligoasthenoteratozoospermia)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

ОАЭ · 1 центр

• ART Fertility Clinics LLC — Abu Dhabi

Публикации

• 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. PMID 23622971
• 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. PMID 24627670
• 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. PMID 27352270
• 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. PMID 22890422
• 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. PMID 31208261
• 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. PMID 19153090
• 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. PMID 25008235

Идентификаторы

NCT: NCT05837325 · 2212-ABU-015-LM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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