Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

Last updated: March 26, 2025
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

anti-inflammatory diet

Clinical Study ID

NCT06885125
DANTE Study
  • Ages 18-39
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age < 40 years

  • Pregnancy seeking for more than 12 months

  • Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days

  • Ultrasonographic diagnosis of ovarian endometriomas or deep peritonealendometriosis.

  • Antral Follicle Counts (AFC) ≥ 5 (no other cause of reduced ovarian reserve).

  • Absence of ureteral stenosis or intestinal subocclusive symptoms

Exclusion

Exclusion Criteria:

  • Contraindication to pregnancy

  • Hydrosalpinx

  • Endometriomas with a mean diameter > 4 cm

  • Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).

  • Doubtful sonographic findings that do not allow to reliably rule out malignancy.

  • severe male factor (<1 million sperm/ml)

Study Design

Total Participants: 438
Treatment Group(s): 1
Primary Treatment: anti-inflammatory diet
Phase:
Study Start date:
March 24, 2025
Estimated Completion Date:
December 31, 2029

Study Description

Women who agree to participate in the study will be randomized into two groups: one group will receive standard IVF protocols, and the other will undergo a 12-week anti-inflammatory diet followed by the standard IVF protocol. In both groups, participants' dietary habits will be monitored throughout the study period to detect any variations. The primary outcome will be to compare the rate of inadequate ovarian response to hormonal stimulation (defined as the retrieval of ≤3 oocytes according to the Poseidon 2016 criteria) in infertile women with endometriosis.

Connect with a study center

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

    Active - Recruiting

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