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

NCT05837325 | Recruiting DMC

• 1 other identifier: 2212-ABU-015-LM
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Female; Infertility

Keywords

Estradiol; FSH; LH; AMH; Ploidy; Chromosomes; Infertility; Progesterone; Inhibin B

Outcome Measures

Primary Outcomes (6)

• Oocyte maturity

  Calculated as percentage transformation of an oocyte from prophase I to metaphase II

  1 day

• Fertilization

  Percentage of mature oocytes - metaphase II (MII) that become 2 pronucleii embryos (2PN)

  1 day

• Blastulation

  Ability of the embryo to form a cavity (=to blastulate) 114-118 hours post ICSI. Number of blastocysts divided by the number of 2PN

  1 day

• Blastocyst quality

  Four Embryo Quality Scores (EQ1, 2, 3, 4) based on the expansion stage of the blastocyst, the grade of the inner cell mass and the grade of the trophectoderm.

  6 days

• Ploidy status

  Determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development

  14 days

• Mitochondria status

  Measured as mtDNA ratio, the ratio of mitochondrial DNA (mtDNA) read counts to autosomal (chromosome 1-22) DNA read counts

  14 days

Secondary Outcomes (18)

• AMH in the follicular fluid.

  1 day

• FSH in the follicular fluid.

  1 day

• LH in the follicular fluid.

  1 day

• E2 in the follicular fluid.

  1 day

• P4 in the follicular fluid.

  1 day

Study Arms (2)

Study Group

Procedure: ICSI; Procedure: Culture; Genetic: Biopsy; Procedure: Vitrification; Procedure: OPU - Study Group; Procedure: Denudation - Study Group

Out of Study Group

Procedure: Oocyte Pick Up - Out of Study; Procedure: Denudation - Out of Study; Procedure: ICSI; Procedure: Culture; Genetic: Biopsy; Procedure: Vitrification

Interventions

Oocyte Pick Up - Out of Study PROCEDURE

Aspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish.

Out of Study Group

Denudation - Out of Study PROCEDURE

All oocytes are denuded together. Maturational stages are recorded.

Out of Study Group

ICSI PROCEDURE

One oocyte injected at a time.

Out of Study Group; Study Group

Culture PROCEDURE

One embryo per culture drop. Individual follow-up of the embryo development.

Out of Study Group; Study Group

Biopsy GENETIC

One embryo per culture drop.

Out of Study Group; Study Group

Vitrification PROCEDURE

One embryo per vitrification straw.

Out of Study Group; Study Group

OPU - Study Group PROCEDURE

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).

Study Group

Denudation - Study Group PROCEDURE

Oocyte included in the study will be denuded separately. Maturational stages are recorded per follicle.

Study Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female undergoing IVF treatment

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Follicular fluid Blood sample

MeSH Terms

Conditions

Infertility, Female; Infertility

Interventions

Sperm Injections, Intracytoplasmic; Culture Techniques; Biopsy; Vitrification

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; In Vitro Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Phase Transition; Physical Phenomena

Study Officials

• Laura Melado, PhD

  ART Fertility Clinics LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Lawrenz, PhD

CONTACT

0097126528000; barbara.lawrenz@artfertilityclinics.com

Suzan Samir

CONTACT

0097126528000; suzan.samir@artfertilityclinics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: May 1, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-06

Locations

AE (1)