NCT06885125Recruiting
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
Randomized Controlled Study on the Effect of a DietAry interveNtion in Ameliorating fertiliTy Parameters in Women With endomEtriosis Undergoing IVF (The DANTE Study)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 438 (estimated)
- First submitted
- 5 Feb 2025
- Start date
- 24 Mar 2025
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Diseases
- Endometriosis
- NCT number
- NCT06885125
What you commit to
- Study type: Interventional
- Planned participants: 438
- From 24 Mar 2025 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Doubtful sonographic findings that do not allow to reliably rule out malignancy.
Other
- Contraindication to pregnancy
- Hydrosalpinx
- Endometriomas with a mean diameter \> 4 cm
- Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).
- severe male factor (\<1 million sperm/ml)
Who the study is looking for
- 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
Age in the registry: 18 years to 39 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.