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The Role of the Physiological Endometrial Microbiota in Assisted Reproduction Outcomes (no exist)

2026年5月20日 更新者：Assisting Nature

The goal of this observational study is to investigate the influence and contribution of the normal composition and balance of the endometrial microbiota on the achievement of embryo implantation and the maintenance of pregnancy in women undergoing IVF, with comparable clinical profiles, including patients with a history of RIF or RPL, evaluated under identical treatment protocols and hormonal conditions.

The main questions it aims to answer are:

  1. Does the normal composition of the endometrial microbiota, particularly the dominance of Lactobacillus species, influence embryo implantation success in women undergoing IVF?
  2. Does the endometrial microbiota profile affect pregnancy maintenance, ongoing pregnancies, and live birth rates in women with a history of recurrent implantation failure (RIF) or recurrent pregnancy loss (RPL)

Participants will not undergo any additional interventions beyond standard clinical care.They will provide clinical data already collected as part of routine IVF procedures.

調査の概要

状態

招待による登録

条件

詳細な説明

Endometrial biopsies were collected from patients using a Pipelle catheter during the designated phase of the menstrual cycle. Each sample was immediately placed in a specialized preservative solution and transported to two external laboratories for analysis.

In the first laboratory, bacterial DNA was extracted using a CE-IVD kit, followed by targeted amplification and barcoded sequencing of seven hypervariable regions (V2, V3, V4, V6, V7, V8, V9) of the 16S rRNA gene using the 16STM metagenomic kit and Ion Torrent sequencing system (Ion GeneStudio S5 with Ion Chef Instrument). Data were analyzed with Ion Reporter™ software and MicroSEC ID, using MicroSEC ID and Greengenes databases for taxonomic classification.

In the second laboratory, total DNA was extracted, and targeted amplification of the 16S rRNA gene was performed using the 16S Barcoding Kit 24 V14 (Nanopore), followed by NGS on the MinION Mk1C analyzer. Bioinformatic analysis was conducted using the EPI2ME Labs 16S workflow. Bacterial composition was classified at the genus level, with results expressed as relative abundance percentages. OTU-level data were not disclosed.

Interpretation of microbiota profiles was performed by the treating physician or clinical geneticist. Patients whose samples showed decreased Lactobacillus abundance or the presence of potentially pathogenic microorganisms received individualized interventions. These interventions included a two-week course of antibiotics tailored to the patient's clinical history, followed by probiotics administered orally or via combined oral and vaginal routes for two weeks to two months. Antifungal agents were administered when clinically indicated.

Embryo transfer schedules were adapted based on microbial profiles and clinical assessment. Patients with normal microbial profiles proceeded with IVF in the next cycle. Patients with abnormal profiles, signs of inflammation, or potential pathogenic colonization had embryo transfer postponed for at least one month following completion of the therapeutic regimen.

The study provides a detailed methodological framework for endometrial microbiota analysis, including sample collection, DNA extraction, sequencing strategies, bioinformatic pipelines, and clinical decision-making based on microbial composition, aiming to support personalized management in assisted reproduction.

研究の種類

観察的

入学 (推定)

80

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Participants were required to be between 18 and 54 years of age, in accordance with the legally permitted age limits for embryo transfer in Greece

説明

Inclusion Criteria:

  1. Individuals who are biologically female.
  2. Age between 18 and 54 years, in accordance with the legally permitted age limits for embryo transfer in Greece.
  3. Undergoing in vitro fertilization (IVF) treatment.
  4. Clinical history consistent with recurrent implantation failure (RIF) or recurrent pregnancy loss (RPL) and comparable IVF treatment profiles.
  5. Ability to provide informed consent for the use of clinical and microbiome data for research purposes

Exclusion Criteria:

  1. Individuals who are not biologically female.
  2. Age below 18 or above 54 years.
  3. Absence of endometrial biopsy samples or incomplete clinical data.
  4. Presence of significant uterine abnormalities or medical conditions that contraindicate embryo transfer.
  5. Participation in another interventional clinical study that may interfere with microbiome assessment or IVF outcomes.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Lactobacillus-dominant microbiota
Participants whose endometrial microbiota is dominated by Lactobacillus species. Data were collected from previously obtained endometrial biopsies, analyzed via 16S rRNA gene sequencing. No interventions were performed beyond standard IVF clinical care.
Non-Lactobacillus-dominant microbiota
Participants whose endometrial microbiota shows depletion of Lactobacillus species or presence of potentially pathogenic microorganisms. Data were collected from previously obtained endometrial biopsies, analyzed via 16S rRNA gene sequencing. In some cases, participants received individualized clinical interventions (e.g., antibiotics or probiotics) based on their microbial profile as part of routine care.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Implantation Rate according to microbiome profile
時間枠：From the day of the embryo transfer to the day of confirmation of implantation (2-4 weeks)
The study formally assesses differences in embryo implantation rates between women with Lactobacillus-dominant and non-Lactobacillus-dominant endometrial microbiota profiles.
From the day of the embryo transfer to the day of confirmation of implantation (2-4 weeks)
Ongoing Pregnancy/Live Birth Rate according to microbiome profile
時間枠：From the day of embryo transfer up to the end of the first trimester (up to 12 weeks of gestation) and live birth until delivery (up to 40 weeks of gestation)
Association between endometrial microbiota composition and the likelihood of achieving an ongoing pregnancy or live birth
From the day of embryo transfer up to the end of the first trimester (up to 12 weeks of gestation) and live birth until delivery (up to 40 weeks of gestation)
Biochemical pregnancy rate and microbiome status
時間枠：From the day of embryo transfer to the day of confirmation of implantation (2-4 weeks)
Rate of biochemical pregnancies in relation to endometrial microbiota profile
From the day of embryo transfer to the day of confirmation of implantation (2-4 weeks)

二次結果の測定

結果測定
メジャーの説明
時間枠
Endometrial microbiota composition
時間枠：At time of biopsy collection (during procedure)
Relative abundance of Lactobacillus versus non-Lactobacillus genera in endometrial biopsies analyzed by 16S rRNA sequencing.
At time of biopsy collection (during procedure)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Assisting Nature

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年1月2日

一次修了 (推定)

2026年5月30日

研究の完了 (推定)

2026年6月25日

試験登録日

最初に提出

2026年2月20日

QC基準を満たした最初の提出物

2026年5月20日

最初の投稿 (実際)

2026年5月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月26日

QC基準を満たした最後の更新が送信されました

2026年5月20日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • Microbiome-AN011
  • Assisting Nature (その他の識別子：Assisting Nature IVF Clinic)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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