Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

NCT06885125 | Recruiting DMC

• 1 other identifier: DANTE Study
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

IVF; endometriosis; anti-inflammatory diet

Outcome Measures

Primary Outcomes (1)

• 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.

  During the oocyte retrieval procedure

Secondary Outcomes (12)

• Adherence to the intervention

  3 months

• Fertilisation rate

  The day after oocyte retrieval

• Embryo quality

  Up to six days after oocyte pick-up

• Cumulative pregnancy rates

  12 months

• Miscarriage rate

  24 months

Study Arms (2)

Anti-Inflammatory Diet

EXPERIMENTAL

Patients will follow a 12-week anti-inflammatory diet, followed by the standard IVF treatment protocol.

Dietary Supplement: anti-inflammatory diet

Controls

NO INTERVENTION

Patients will undergo the standard IVF treatment protocol without any dietary intervention.

Interventions

anti-inflammatory diet DIETARY_SUPPLEMENT

The anti-inflammatory diet consists of a 12-week plant-based diet, followed by guidance and monitoring from a nutritionist.

Anti-Inflammatory Diet

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• UNIVERSITE CATHOLIQUE DE LOUVAIN: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• University of Edinburgh: collaborator
• STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM: collaborator
• UNIWERSYTET MEDYCZNY W LUBLINIE: collaborator
• SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET: collaborator
• University College Cork: collaborator
• Endometriosis UK: collaborator
• Wageningen University: collaborator
• Endometriose Stichting: collaborator
• Belgian Volition SRL: collaborator
• ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10: collaborator

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Paola Vigano', PhD

CONTACT

+390255034302; paola.vigano@policlinico.mi.it

Marco Reschini, MSc

CONTACT

+390255034303; marco.reschini@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The treatment will be kept blind for both the medical and laboratory personnel performing the in vitro fertilization procedures. The allocation branch will be revealed to the data manager at the end of data collection related to the primary outcome.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: March 20, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)