NCT Number: NCT05837325
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.
Interested in participating?
Request Info18 year–40 year
Female
Observational
Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates
Location status: Recruiting
Barbara Lawrenz, PhD
CONTACT
0097126528000 ext. 1108
Ibrahim ElKhatib
SUB_INVESTIGATOR
Jonalyn Edades
CONTACT
0097126528000 ext. 1106
Laura Melado, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aspiration of follicles. search for the oocyte(s) All oocytes are grouped in one dish.
All oocytes are denuded together. Maturational stages are recorded.
One oocyte injected at a time.
One embryo per culture drop. Individual follow-up of the embryo development.
One embryo per culture drop.
One embryo per vitrification straw.
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).
Oocyte included in the study will be denuded separately. Maturational stages are recorded per follicle.
Time frame: 1 day
Calculated as percentage transformation of an oocyte from prophase I to metaphase II
Time frame: 1 day
Percentage of mature oocytes - metaphase II (MII) that become 2 pronucleii embryos (2PN)
Time frame: 1 day
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: 6 days
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: 14 days
Determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development
Time frame: 14 days
Measured as mtDNA ratio, the ratio of mitochondrial DNA (mtDNA) read counts to autosomal (chromosome 1-22) DNA read counts
Time frame: 1 day
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 day
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 day
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 day
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 day
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
Time frame: 1 day
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
Time frame: 1 day
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 day
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 day
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 day
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 day
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
Time frame: 1 day
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
Time frame: 1 day
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 day
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 day
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 day
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 day
To evaluate if there is an association between serum P4 on day 2-3 of the stimulation, serum P4 day of OPU and the intra-follicular P4.
Time frame: 1 day
To evaluate if there is an association between serum Inhibin B on day 2-3 of the stimulation, serum Inhibin B day of OPU and the intra-follicular Inhibin B.
Contact information is provided by the study sponsor or research team.
ART Fertility Clinics LLC
Other
Is the AMH Intrafollicular Level a Predictor of the Ploidy Status of the Blastocyst? A Prospective Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03989778
Avitaminosis, Deficiency Diseases
Karachi, Sindh, Pakistan
View Trial DetailsNCT06539104
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Prague, Czechia
View Trial DetailsNCT03712982
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Waltham, Massachusetts, United States
View Trial DetailsNCT03085212
Behavior, Behavioral Symptoms
Columbus, Ohio, United States
View Trial Details