Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

Summary

The goal of this randomized controlled trial is to assess whether a 12-week anti-inflammatory diet can improve fertility outcomes in women with endometriosis undergoing In Vitro Fertilization (IVF).

The main questions are:

* Does the anti-inflammatory diet reduce the rate of inadequate ovarian response to hormonal stimulation (retrieval of ≤3 oocytes)?
* Does it improve secondary outcomes such as embryo quality, pregnancy rates, inflammation markers, and quality of life?

Researchers will compare two groups:

* Women receiving standard IVF protocols.
* Women undergoing the same IVF protocol plus the anti-inflammatory diet.

Participants will:

* Be randomized into one of the two groups.
* Follow dietary counseling sessions and complete dietary assessments (diet group).
* Provide biological samples (e.g., plasma, vaginal and fecal swabs, and follicular fluid) before and after the dietary intervention to evaluate potential differences in inflammation, hormonal levels, and microbiome composition between the two groups and across timepoints (pre- and post-diet).
* Complete questionnaires on quality of life, sexual function, and symptomatology severity before and after the intervention to assess differences between the two groups and across timepoints.

Conditions

• Endometriosis

Interventions

DIETARY_SUPPLEMENT

anti-inflammatory diet

The anti-inflammatory diet consists of a 12-week plant-based diet, followed by guidance and monitoring from a nutritionist.

Sponsors & Collaborators

• UNIVERSITE CATHOLIQUE DE LOUVAIN

  collaborator UNKNOWN

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM

  collaborator UNKNOWN

• UNIWERSYTET MEDYCZNY W LUBLINIE

  collaborator UNKNOWN

• SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET

  collaborator UNKNOWN

• University College Cork

  collaborator OTHER

• Endometriosis UK

  collaborator UNKNOWN

• Wageningen University

  collaborator OTHER

• Endometriose Stichting

  collaborator UNKNOWN

• Belgian Volition SRL

  collaborator UNKNOWN

• ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10

  collaborator UNKNOWN

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-24

Primary Completion

2029-06-30

Completion

2029-12-31

Countries

• Italy

Study Locations