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Recruiting NCT06885125

Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

No phase Interventional Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: anti-inflammatory diet.
Who it may be relevant to
Registry conditions: Endometriosis. Basic parameters: 18 years — 39 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Controlled Study on the Effect of a DietAry interveNtion in Ameliorating fertiliTy Parameters in Women With endomEtriosis Undergoing IVF (The DANTE Study)

Overview

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.

Detailed 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.

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.

Primary outcome measures

  • Inadequate ovarian response [Time frame: During the oocyte retrieval procedure]
Secondary outcome measures (12)
  • Adherence to the intervention [Time frame: 3 months]
  • Fertilisation rate [Time frame: The day after oocyte retrieval]
  • Embryo quality [Time frame: Up to six days after oocyte pick-up]
  • Cumulative pregnancy rates [Time frame: 12 months]
  • Miscarriage rate [Time frame: 24 months]
  • Cumulative Live Birth Rate [Time frame: 24 months]
  • Microbiome composition [Time frame: 4 months]
  • Concentration of Steroid Hormones [Time frame: 4 months]
  • Inflammation Index [Time frame: 4 months]
  • Quality of life (using 30-item Endometriosis Health Profile) [Time frame: 4 months]
  • Sexual function (using Female Sexual Function Index) [Time frame: 4 months]
  • Symptomatology severity (using Numeric Rating Scale) [Time frame: 4 months]

Eligibility criteria

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 peritoneal endometriosis.
  • Antral Follicle Counts (AFC) ≥ 5 (no other cause of reduced ovarian reserve).
  • Absence of ureteral stenosis or intestinal subocclusive symptoms

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan

Publications

  • Vigano P, Abodi M, Benaglia L, Bolis I, Casalechi M, Ferraro C, Li Piani L, Reschini M, Ruggiero F, Salmeri N, Somigliana E, Horne AW, Nap AW, Dolmans MM; EUmetriosis Working Group. Effectiveness of an anti-inflammatory diet before in vitro fertilisation in women with endometriosis: protocol for a randomised controlled trial. BMJ Open. 2025 Dec 23;15(12):e108596. doi: 10.1136/bmjopen-2025-108596. PMID 41436256

Identifiers

NCT: NCT06885125 · DANTE Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗