NCT06885125 Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
| NCT ID | NCT06885125 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 438 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 438 participants in total. It began in 2025-03-24 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06885125 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 39 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06885125 currently recruiting?
Yes, NCT06885125 is actively recruiting participants. Contact the research team at paola.vigano@policlinico.mi.it for enrollment information.
Where is the NCT06885125 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06885125 clinical trial?
NCT06885125 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 438 participants.