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临床试验/NCT04820985
NCT04820985已完成不适用

Analyse de la Composition du Microbiote Vaginal à différents Temps de la Prise en Charge en FIV et corrélation Avec le Taux de progestérone sérique le Jour du Transfert d'Embryon

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Microbiota richness of vaginal flora

研究概览

简要总结

The composition of the vaginal microbiota varies throughout a woman's life and is sensitive to hormonal and environmental factors. Specifically, hormonal treatments necessary in the medically assisted procreation (MAP) processes can influence the vaginal microbiota. New sequencing techniques have been used to characterize the vaginal microbiota, demonstrating that the microbiota could be divided into 5 classes. The composition of the vaginal microbiota seems to have an implication in the evolution of a pregnancy after IVF. It is therefore essential to have more data on the evolution of the vaginal microbiota at the different stages of IVF treatment and to analyze whether this evolution can be predictive of the success of embryo implantation. Good endometrial progesterone impregnation is an essential prerequisite for ensuring embryo implantation. Indeed, supporting the luteal phase through vaginal progesterone is an essential step in IVF protocols to ensure synchronization between endometrial maturation and embryonic age. However, the serum progesterone level on the day of embryo transfer varies widely between patients. Several factors such as age, vaginal mucosa trophicity, estrogen impregnation and sexual activity are known to affect the vaginal absorption of progesterone. The treatments and vaginal examinations performed during the IVF procedure could also have an impact on the constitution of the vaginal microbiota. The hypothesis of this research is that there is an alteration in the vaginal microbiota during the IVF process which may alter the absorption of vaginal progesterone, with an impact on the failure or success of embryo implantation.

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

  • Patient in round 1 or 2 of IVF or IVF-ICSI with transfer of a fresh embryo with a normal preimplantation assessment, without antibiotic treatment in the 3 months preceding the sample.
  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan

排除标准

  • Use of antibiotics in the 3 months preceding the sample.
  • Patient presenting an anomaly in the implantation assessment.
  • Presence of uterine malformation, hydrosalpinx, chronic vaginosis.
  • Patient undergoing a protocol to study endometrial receptivity.
  • Patient of African American, African or Latin American origin (patients born to two parents of Hispanic origin) as people of African and Hispanic origin have a type IV flora vs people of Caucasian origins who have type I, II, III and V of the Ravel classification .
  • Cancellation of the procedure for various reasons (stimulation failure, collection failure, fertilization failure or embryonic segmentation).
  • Patient taking a freeze-all approach (freezing of the embryos) for various causes (risk of ovarian hyperstimulation, increase in progesterone, too thin endometrium, etc.).
  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship

结局指标

主要结局

Microbiota richness of vaginal flora

时间窗: 3 Months before ovarian stimulation

Measured by operational taxonomic unit

Microbiota alpha diversity of vaginal flora

时间窗: 3 Months before ovarian stimulation

Shannon Index

Microbiota beta diversity of vaginal flora

时间窗: 3 Months before ovarian stimulation

Bray Curtis index

Class of vaginal flora according to community state type

时间窗: 3 Months before ovarian stimulation

Classified into 5 classes of vaginal flora described according to Smith \& Ravel 2017

Plasma progesterone level on the day of embryo transfer

时间窗: Day of embryo transfer (Day 0)

Measured by chemiluminescence (nmol/L)

次要结局

  • Pregnancy success(Month 3)
  • Treatments received for IVF(Month 3)
  • Pregnancy progression(Month 3)
  • Plasma progesterone level(Month 3)
  • Class of vaginal flora according to community state type(Day of beta-human chorionic gonadotropin dosage (Day 108))
  • Microbiota beta diversity of vaginal flora(Day of beta-human chorionic gonadotropin dosage (Day 108))
  • Microbiota richness of vaginal flora(Day of beta-human chorionic gonadotropin dosage (Day 108))
  • Microbiota alpha diversity of vaginal flora(Day of beta-human chorionic gonadotropin dosage (Day 108))

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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