Clinical trial NCT05837325: Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst?
Official title: Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst? A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility, Female
Infertility
Keywords: Estradiol
FSH
LH
AMH
Ploidy
Chromosomes
Infertility
Progesterone
Inhibin B
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female undergoing IVF treatment

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Oocyte maturity
timeFrame: 1 day
measure: Fertilization
timeFrame: 1 day
measure: Blastulation
timeFrame: 1 day
measure: Blastocyst quality
timeFrame: 6 days
measure: Ploidy status
timeFrame: 14 days
measure: Mitochondria status
timeFrame: 14 days
Secondary outcomes:
measure: AMH in the follicular fluid.
timeFrame: 1 day
measure: FSH in the follicular fluid.
timeFrame: 1 day
measure: LH in the follicular fluid.
timeFrame: 1 day
measure: E2 in the follicular fluid.
timeFrame: 1 day
measure: P4 in the follicular fluid.
timeFrame: 1 day
measure: Inhibin B in the follicular fluid.
timeFrame: 1 day
measure: AMH in serum day of OPU
timeFrame: 1 day
measure: FSH in serum day of OPU
timeFrame: 1 day
measure: LH in serum day of OPU
timeFrame: 1 day
measure: E2 in serum day of OPU
timeFrame: 1 day
measure: P4 in serum day of OPU
timeFrame: 1 day
measure: Inhibin B in serum day of OPU
timeFrame: 1 day
measure: AMH in serum day of day 2/3 of stimulation.
timeFrame: 1 day
measure: FSH in serum day of day 2/3 of stimulation.
timeFrame: 1 day
measure: LH in serum day of day 2/3 of stimulation.
timeFrame: 1 day
measure: E2 in serum day of day 2/3 of stimulation.
timeFrame: 1 day
measure: P4 in serum day of day 2/3 of stimulation.
timeFrame: 1 day
measure: Inhibin B in serum day of day 2/3 of stimulation.
timeFrame: 1 day
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics LLC
Study officials:
affiliation: ART Fertility Clinics LLC
name: Laura Melado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.