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Hippo-Related Competing Endogenous RNA (ceRNA) Network Dysregulation and In Vitro Fertilization (IVF) Outcomes in Women With Diminished Ovarian Reserve (DOR-HIPPO-IVF)

2026年6月17日 更新者：Abeer Othman Fahmi Mohammed、Assiut University

Investigating the Dysregulation of the Hippo-Related ceRNA Network and Its Impact on IVF Outcomes in Patients With Diminished Ovarian Reserve (DOR)

Diminished Ovarian Reserve (DOR) is an important cause of female infertility and is associated with poor ovarian response and lower pregnancy rates during In Vitro Fertilization (IVF). The molecular mechanisms underlying impaired follicular development in DOR remain incompletely understood. Increasing evidence suggests that non-coding RNAs and components of the Hippo signaling pathway play important roles in granulosa cell proliferation, apoptosis, and follicular development.

This prospective observational cohort study aims to investigate the expression of the long non-coding RNA (lncRNA) Nuclear Paraspeckle Assembly Transcript 1 (NEAT1), microRNA (miRNA)-181a-5p, Hippo pathway components including Yes-Associated Protein 1 (YAP1) and Connective Tissue Growth Factor (CTGF), and Insulin-Like Growth Factor 1 (IGF1) in follicular fluid-derived cells from women with DOR undergoing IVF compared with women with normal ovarian reserve. The study will also evaluate relationships among these molecular markers and IVF outcomes, including oocyte quality, number of retrieved oocytes, and embryo developmental potential.

調査の概要

状態

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条件

詳細な説明

Infertility affects a significant proportion of reproductive-aged couples worldwide, and female infertility contributes substantially to these cases. Diminished ovarian reserve (DOR) is characterized by reduced quantity and quality of ovarian follicles and is associated with impaired oocyte competence and reduced success rates during assisted reproductive technologies.

Recent evidence highlights the importance of the Hippo signaling pathway in ovarian physiology and folliculogenesis. Yes-Associated Protein 1 (YAP1), a major downstream effector of Hippo signaling, regulates granulosa cell proliferation and survival. Dysregulation of YAP1 and its downstream target Connective Tissue Growth Factor (CTGF) may contribute to abnormal follicular development and ovarian dysfunction.

Non-coding RNAs, including long non-coding RNAs (lncRNAs) and microRNAs (miRNAs), have emerged as important regulators of ovarian function. Nuclear Paraspeckle Assembly Transcript 1 (NEAT1) has been implicated in granulosa cell proliferation and ovarian disorders through its function as a competing endogenous RNA (ceRNA). miR-181a-5p has been shown to regulate cell proliferation and apoptosis and may target YAP1 expression.

This study will investigate the proposed NEAT1/miR-181a-5p/Hippo signaling regulatory axis in women with DOR undergoing IVF treatment. Follicular fluid-derived cells and follicular fluid samples will be analyzed for expression of NEAT1, miR-181a-5p, YAP1, CTGF, and IGF1. Associations between these biomarkers and IVF outcomes will also be evaluated.

研究の種類

観察的

入学 (推定)

70

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。

研究連絡先

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

Follicular fluid samples will be aspirated during ultrasound-guided oocyte retrieval procedures. Blood-contaminated samples will be excluded. Samples will be centrifuged to separate follicular fluid from cellular pellets.

Supernatants will be stored at -80°C for biochemical analysis. Cellular pellets will undergo ribonucleic acid (RNA) and protein extraction.

Total ribonucleic acid (RNA) extraction will be performed using TRIzol reagent followed by complementary deoxyribonucleic acid (cDNA) synthesis. Quantitative Real-Time Polymerase Chain Reaction (qRT-PCR) will be used to measure NEAT1, miR-181a-5p, CTGF, and IGF1 expression levels.

YAP1 protein expression will be analyzed using Western blotting.

説明

Inclusion Criteria:

  • Women undergoing In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) cycles.
  • Infertility duration of at least one year
  • Primary or secondary infertility.

Exclusion Criteria:

  • Polycystic Ovary Syndrome (PCOS)
  • Endometriosis.
  • Ovarian tumors or malignancy.
  • Severe systemic diseases affecting fertility.
  • Metabolic syndrome.
  • Connective tissue disorders.
  • Hormonal therapy within the last three months.
  • Refusal to participate.

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
Group 1: Control Group

Group 1: Control Group

Women with normal ovarian reserve undergoing In Vitro Fertilization (IVF) due to non-ovarian causes of infertility such as male factor infertility or tubal factor infertility.
Group 2: DOR Group

Group 2: DOR Group

Women diagnosed with diminished ovarian reserve according to at least two of the following criteria:

Anti-Müllerian Hormone (AMH) ≤1.1 ng/mL

Antral Follicle Count (AFC) ≤7

Basal Follicle-Stimulating Hormone (FSH) ≥10 IU/L

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
Expression levels of Nuclear Paraspeckle Assembly Transcript 1 (NEAT1), microRNA-181a-5p (miR-181a-5p), Yes-Associated Protein 1 (YAP1), and Connective Tissue Growth Factor (CTGF).
時間枠：At oocyte retrieval during the participant's IVF cycle (approximately 10-14 days after initiation of controlled ovarian stimulation).
Assessment of gene and protein expression levels in follicular fluid-derived cells from women with Diminished Ovarian Reserve (DOR) compared with controls.
At oocyte retrieval during the participant's IVF cycle (approximately 10-14 days after initiation of controlled ovarian stimulation).

二次結果の測定

結果測定
メジャーの説明
時間枠
Association Between NEAT1 and miR-181a-5p Expression
時間枠：At oocyte retrieval during the participant's IVF cycle (approximately 10-14 days after initiation of controlled ovarian stimulation).
Evaluation of the relationship between NEAT1 and miR-181a-5p expression levels.
At oocyte retrieval during the participant's IVF cycle (approximately 10-14 days after initiation of controlled ovarian stimulation).
Association Between miR-181a-5p and Hippo Pathway Components
時間枠：At oocyte retrieval during the participant's IVF cycle (approximately 10-14 days after initiation of controlled ovarian stimulation).
Assessment of correlations between miR-181a-5p and YAP1/CTGF expression.
At oocyte retrieval during the participant's IVF cycle (approximately 10-14 days after initiation of controlled ovarian stimulation).
Insulin-Like Growth Factor 1 (IGF1) Levels in Follicular Fluid
時間枠：At oocyte retrieval during the participant's IVF cycle (approximately 10-14 days after initiation of controlled ovarian stimulation).
Measurement of IGF1 levels and their association with molecular markers.
At oocyte retrieval during the participant's IVF cycle (approximately 10-14 days after initiation of controlled ovarian stimulation).
Association With IVF Outcomes
時間枠：Assessed on the day of oocyte retrieval (approximately 10-14 days after initiation of controlled ovarian stimulation)
Number of retrieved oocytes
Assessed on the day of oocyte retrieval (approximately 10-14 days after initiation of controlled ovarian stimulation)
Association With IVF Outcomes
時間枠：Assessed at blastocyst evaluation, 5-6 days after fertilization
Embryo development potential
Assessed at blastocyst evaluation, 5-6 days after fertilization
Association With IVF Outcomes
時間枠：Assessed on the day of oocyte retrieval and fertilization assessment (within 0-1 day after oocyte retrieval)
Oocyte quality
Assessed on the day of oocyte retrieval and fertilization assessment (within 0-1 day after oocyte retrieval)

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

Assiut University

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 (推定)

2026年8月1日

一次修了 (推定)

2028年2月1日

研究の完了 (推定)

2028年10月1日

試験登録日

最初に提出

2026年6月13日

QC基準を満たした最初の提出物

2026年6月17日

最初の投稿 (実際)

2026年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月22日

QC基準を満たした最後の更新が送信されました

2026年6月17日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • DOR-Hippo-ceRNA-IVF-2026

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?

いいえ

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

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