NCT05837325

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: ART Fertility Clinics LLC · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

• Infertility, Female
• Infertility

Interventions

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

Timeline

• Start date: 2023-05-23
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2023-05-01
• Last updated: 2025-10-02

Locations

1 site across 1 country: United Arab Emirates