Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
FEMALE
NCT06885125

Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-03-27

438

Participants Needed

1

Research Sites

249 weeks

Total Duration

On this page

Sponsors

F

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Lead Sponsor

U

Université Catholique de Louvain

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

Who Can Participate

Age: 18Years - 39Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age under 40 years
  • Seeking pregnancy for more than 12 months
  • Regular menstrual cycles with intervals between 21 and 35 days
  • Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis
  • Antral Follicle Count of 5 or more with no other cause of reduced ovarian reserve
  • No ureteral stenosis or intestinal subocclusive symptoms
Not Eligible

You will not qualify if you...

  • Contraindication to pregnancy
  • Presence of hydrosalpinx
  • Endometriomas larger than 4 cm in diameter
  • Submucosal fibroids or large intramural or subserosal fibroids 5 cm or larger
  • Uncertain sonographic findings that do not rule out malignancy
  • Severe male factor infertility with sperm count below 1 million/ml

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122

Actively Recruiting

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Research Team

P

Paola Vigano', PhD

CONTACT

M

Marco Reschini, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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