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临床试验/NCT05837325
NCT05837325招募中不适用

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

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Oocyte maturity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Oocyte maturity

时间窗: 1 day

Calculated as percentage transformation of an oocyte from prophase I to metaphase II

Fertilization

时间窗: 1 day

Percentage of mature oocytes - metaphase II (MII) that become 2 pronucleii embryos (2PN)

Blastulation

时间窗: 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

Blastocyst quality

时间窗: 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.

Ploidy status

时间窗: 14 days

Determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development

Mitochondria status

时间窗: 14 days

Measured as mtDNA ratio, the ratio of mitochondrial DNA (mtDNA) read counts to autosomal (chromosome 1-22) DNA read counts

次要结局

  • P4 in the follicular fluid.(1 day)
  • FSH in serum day of OPU(1 day)
  • LH in serum day of OPU(1 day)
  • AMH in serum day of day 2/3 of stimulation.(1 day)
  • P4 in serum day of day 2/3 of stimulation.(1 day)
  • LH in the follicular fluid.(1 day)
  • E2 in the follicular fluid.(1 day)
  • Inhibin B in serum day of day 2/3 of stimulation.(1 day)
  • Inhibin B in the follicular fluid.(1 day)
  • P4 in serum day of OPU(1 day)
  • Inhibin B in serum day of OPU(1 day)
  • AMH in the follicular fluid.(1 day)
  • FSH in the follicular fluid.(1 day)
  • AMH in serum day of OPU(1 day)
  • LH in serum day of day 2/3 of stimulation.(1 day)
  • E2 in serum day of day 2/3 of stimulation.(1 day)
  • E2 in serum day of OPU(1 day)
  • FSH in serum day of day 2/3 of stimulation.(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Melado

Principal Investigator

ART Fertility Clinics LLC

研究点 (1)

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