EndometriosisDANTENCT06885125
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
A study testing anti-inflammatory diet in people with Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- anti-inflammatory diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteItaly
- Study dates
- 24 Mar 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Paola Vigano', PhD, +390255034302, paola.vigano@policlinico.mi.it
Marco Reschini, MSc, +390255034303, marco.reschini@policlinico.mi.it
About this study
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)
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:
Read more
- 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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- anti-inflammatory diet
- Keywords
- IVF, endometriosis, anti-inflammatory diet
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-inflammatory dietDietary supplement
The anti-inflammatory diet consists of a 12-week plant-based diet, followed by guidance and monitoring from a nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| Anti-Inflammatory Diet | Experimental | Patients will follow a 12-week anti-inflammatory diet, followed by the standard IVF treatment protocol. Receives: Dietary Supplement: anti-inflammatory diet |
| Controls | No intervention | Patients will undergo the standard IVF treatment protocol without any dietary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate ovarian response
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 who follow an anti-inflammatory diet compared to those who do not follow any specific diet.
Measured: During the oocyte retrieval procedure
Secondary outcomes (12)
Adherence to the intervention
Adherence to the intervention using 24 hour recall.
Measured: 3 months
Fertilisation rate
Fertilisation rate per aspirated oocyte retrieved. Defined as the appearance of 2 pronuclei (PN)
Measured: The day after oocyte retrieval
Embryo quality
Good quality blastocysts according to Gardner classification
Measured: Up to six days after oocyte pick-up
Cumulative pregnancy rates
All clinical pregnancies achieved by IVF, including the transfer of fresh embryos and all cryopreserved-thawed embryos from the stimulation cycle.
Measured: 12 months
Miscarriage rate
Spontaneous or planned abortions.
Measured: 24 months
Cumulative Live Birth Rate
All live birth achieved by IVF, including the transfer of fresh embryos and all cryopreserved-thawed embryos from the stimulation cycle.
Measured: 24 months
Microbiome composition
The difference in microorganism species distribution according to 16S RNA sequencing analysis between the control group and the study group, as well as before and after the diet in the study group. Both the vaginal and gut microbiome will be analyzed.
Measured: 4 months
Concentration of Steroid Hormones
The difference between the steroid cascade in follicular fluids of women following the diet and those not following the diet, specifically focusing on the following hormones: Aldosterone, Cortisol, Cortisone, 11-DeoxyCortisol, 21-DeoxyCortisol, Corticosterone, 11-Deoxycorticosterone, DHEAS, DHEA, Estradiol, Androstenedione, Testosterone, DHT, 17-OHProgesterone, and Progesterone.
Measured: 4 months
Inflammation Index
The difference in the inflammation index between the control group and the study group, as well as pre- and post-diet changes within the study group, will be evaluated using a composite blood-based inflammation index called the INFLA-score. This index is based on four circulating biomarkers-C-reactive protein (CRP) levels, blood platelet count (Plt), white blood cell count (WBC), and granulocyte-to-lymphocyte ratio (GLR)-and captures both serum and cellular-circulating inflammation.
Measured: 4 months
Quality of life (using 30-item Endometriosis Health Profile)
Quality of life differences between the control group and the study group, as well as pre- and post-diet changes within the study group, will be evaluated using the Endometriosis Health Profile-30 (EHP-30) questionnaire. The EHP-30 consists of 30 items divided into five subscales: 'pain,' 'control and powerlessness,' 'social support,' 'emotional well-being,' and 'self-image.' Each subscale is standardized on a scale from 0 to 100, where lower scores indicate better quality of life.
Measured: 4 months
Sexual function (using Female Sexual Function Index)
Sexual function differences between the control group and the study group, as well as pre- and post-diet changes within the study group, will be evaluated using the Female Sexual Function Index (FSFI), a questionnaire with a score range from 2 to 36, where higher scores indicate better sexual function.
Measured: 4 months
Symptomatology severity (using Numeric Rating Scale)
Symptomatology severity differences between the control group and the study group, as well as pre- and post-diet changes within the study group, will be evaluated using Numeric Rating Scale (NRS, min 0-max 10), where higher scores indicate worse symptom severity.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start24 Mar 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, University of Edinburgh, STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM, UNIWERSYTET MEDYCZNY W LUBLINIE, SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET, University College Cork, Endometriosis UK, Wageningen University, Endometriose Stichting, Belgian Volition SRL, ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885125
- Sponsor's protocol ID
- DANTE Study
- Acronym
- DANTE
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41436256
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06885125
- Acronym / sponsor ID
- DANTE / DANTE Study
- Conditions
- Endometriosis
- Keywords
- IVF, endometriosis, anti-inflammatory diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, University of Edinburgh, STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM, UNIWERSYTET MEDYCZNY W LUBLINIE, SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET, University College Cork, Endometriosis UK, Wageningen University, Endometriose Stichting, Belgian Volition SRL, ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-Inflammatory Diet | Experimental | Dietary Supplement: anti-inflammatory dietPatients will follow a 12-week anti-inflammatory diet, followed by the standard IVF treatment protocol. |
| Controls | No intervention | –Patients will undergo the standard IVF treatment protocol without any dietary intervention. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-inflammatory dietThe anti-inflammatory diet consists of a 12-week plant-based diet, followed by guidance and monitoring from a nutritionist. | Dietary supplement | Anti-Inflammatory Diet |
Primary outcome
Inadequate ovarian response
Time frame: During the oocyte retrieval procedure
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 who follow an anti-inflammatory diet compared to those who do not follow any specific diet.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Derived from this study: PubMed 41436256Vigano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-inflammatory diet in people with Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Vigano', PhD (+390255034302, paola.vigano@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inadequate ovarian response (time frame: During the oocyte retrieval procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06885125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.