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

NCT ID: NCT05837325

Last Updated: 2025-10-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-23

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility, Female Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

ICSI

Intervention Type PROCEDURE

One oocyte injected at a time.

Culture

Intervention Type PROCEDURE

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

Biopsy

Intervention Type GENETIC

One embryo per culture drop.

Vitrification

Intervention Type PROCEDURE

One embryo per vitrification straw.

OPU - Study Group

Intervention Type 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).

Denudation - Study Group

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Denudation - Out of Study

Intervention Type PROCEDURE

All oocytes are denuded together. Maturational stages are recorded.

ICSI

Intervention Type PROCEDURE

One oocyte injected at a time.

Culture

Intervention Type PROCEDURE

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

Biopsy

Intervention Type GENETIC

One embryo per culture drop.

Vitrification

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Denudation - Out of Study

All oocytes are denuded together. Maturational stages are recorded.

Intervention Type PROCEDURE

ICSI

One oocyte injected at a time.

Intervention Type PROCEDURE

Culture

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

Intervention Type PROCEDURE

Biopsy

One embryo per culture drop.

Intervention Type GENETIC

Vitrification

One embryo per vitrification straw.

Intervention Type PROCEDURE

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).

Intervention Type PROCEDURE

Denudation - Study Group

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

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Laura Melado

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Barbara Lawrenz, PhD

Role: CONTACT

0097126528000 ext. 1108

Suzan Samir

Role: CONTACT

0097126528000 ext. 1121

Facility Contacts

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Barbara Lawrenz, PhD

Role: primary

0097126528000 ext. 1108

Jonalyn Edades

Role: backup

0097126528000 ext. 1106

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.

Reference Type BACKGROUND
PMID: 23622971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24627670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27352270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22890422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31208261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19153090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25008235 (View on PubMed)

Other Identifiers

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2212-ABU-015-LM

Identifier Type: -

Identifier Source: org_study_id

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