Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorART Fertility Clinics LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Very hematic follicular fluid
If the COC is not found in the follicular fluid
Azoospermia
Known chromosomal abnormalities
Trial population
Female undergoing IVF treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Oocyte Pick Up - Out of Study
Procedure/SurgeryAspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish.
Denudation - Out of Study
Procedure/SurgeryAll oocytes are denuded together. Maturational stages are recorded.
ICSI
Procedure/SurgeryOne oocyte injected at a time.
Culture
Procedure/SurgeryOne embryo per culture drop. Individual follow-up of the embryo development.
Biopsy
GeneticOne embryo per culture drop.
Vitrification
Procedure/SurgeryOne embryo per vitrification straw.
OPU - Study Group
Procedure/SurgeryMeasure 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
Procedure/SurgeryOocyte included in the study will be denuded separately. Maturational stages are recorded per follicle.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Study Group6 interventions
Group B: Out of Study Group6 interventions
Trial outcomes
Primary outcomes
1
Oocyte maturity
Calculated as percentage transformation of an oocyte from prophase I to metaphase II
Time frame
1 day2
Fertilization
Percentage of mature oocytes - metaphase II (MII) that become 2 pronucleii embryos (2PN)
Time frame
1 day3
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
Time frame
1 day4
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.
Time frame
6 daysSecondary outcomes
1
AMH in the follicular fluid.
To evaluate if there is an association between the levels of serum AMH on day 2-3 of the stimulation, AMH day of OPU and the intra-follicular AMH.
Time frame
1 day2
FSH in the follicular fluid.
To evaluate if there is an association between serum FSH on day 2-3 of the stimulation, serum FSH day of OPU and the intra-follicular FSH.
Time frame
1 day3
LH in the follicular fluid.
To evaluate if there is an association between serum LH on day 2-3 of the stimulation, serum LH day of OPU and the intra-follicular LH.
Time frame
1 day4
E2 in the follicular fluid.
To evaluate if there is an association between serum E2 on day 2-3 of the stimulation, serum E2 day of OPU and the intra-follicular E2.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov