Improving fertility in women with endometriosis through diet during IVF
Randomized Controlled Study on the Effect of a DietAry interveNtion in Ameliorating fertiliTy Parameters in Women With endomEtriosis Undergoing IVF (The DANTE Study)
NA · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT06885125
This study is testing if following an anti-inflammatory diet for 12 weeks can help women with endometriosis have better fertility results during IVF.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 438 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06885125 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of a 12-week anti-inflammatory diet on fertility outcomes in women with endometriosis who are undergoing In Vitro Fertilization (IVF). Participants will be divided into two groups: one receiving standard IVF protocols and the other following the anti-inflammatory diet in addition to the IVF protocol. The study will assess primary outcomes such as the rate of inadequate ovarian response and secondary outcomes including embryo quality, pregnancy rates, inflammation markers, and quality of life. Biological samples will be collected to analyze potential changes in inflammation and hormonal levels.
Who should consider this trial
Good fit: Ideal candidates are women under 40 years old with a diagnosis of endometriosis and a history of infertility for more than 12 months.
Not a fit: Patients with severe male factor infertility or contraindications to pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance fertility outcomes for women with endometriosis undergoing IVF.
How similar studies have performed: While dietary interventions in fertility are being explored, this specific approach combining an anti-inflammatory diet with IVF is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Milan
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Paola Vigano', PhD
- Email: paola.vigano@policlinico.mi.it
- Phone: +390255034302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, IVF, endometriosis, anti-inflammatory diet