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NCT Number: NCT07658846

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

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.

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Key information

Conditions

Diminished Ovarian Reserve Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female In Vitro Fertilization Infertility Infertility, Female Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

    Time frame: 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.

Secondary outcomes

  1. Association Between NEAT1 and miR-181a-5p Expression

    Time frame: 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.

  2. Association Between miR-181a-5p and Hippo Pathway Components

    Time frame: 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.

  3. Insulin-Like Growth Factor 1 (IGF1) Levels in Follicular Fluid

    Time frame: 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.

  4. Association With IVF Outcomes

    Time frame: Assessed on the day of oocyte retrieval (approximately 10-14 days after initiation of controlled ovarian stimulation)

    Number of retrieved oocytes

  5. Association With IVF Outcomes

    Time frame: Assessed at blastocyst evaluation, 5-6 days after fertilization

    Embryo development potential

  6. Association With IVF Outcomes

    Time frame: Assessed on the day of oocyte retrieval and fertilization assessment (within 0-1 day after oocyte retrieval)

    Oocyte quality

Study contacts

Contact information is provided by the study sponsor or research team.

Abeer Othman Fahmi Mohammed

CONTACT

[email protected]

01099067741

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: DOR-HIPPO-IVF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

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.

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