Clinical trial NCT06885125: Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: IVF
endometriosis
anti-inflammatory diet
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: UNIVERSITE CATHOLIQUE DE LOUVAIN
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: University of Edinburgh
name: STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
name: UNIWERSYTET MEDYCZNY W LUBLINIE
name: SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET
name: University College Cork
name: Endometriosis UK
name: Wageningen University
name: Endometriose Stichting
name: Belgian Volition SRL
name: ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10
First posted: 2025-03-20
Enrollment: 438
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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)

Primary outcomes:
measure: Inadequate ovarian response
timeFrame: During the oocyte retrieval procedure
Secondary outcomes:
measure: Adherence to the intervention
timeFrame: 3 months
measure: Fertilisation rate
timeFrame: The day after oocyte retrieval
measure: Embryo quality
timeFrame: Up to six days after oocyte pick-up
measure: Cumulative pregnancy rates
timeFrame: 12 months
measure: Miscarriage rate
timeFrame: 24 months
measure: Cumulative Live Birth Rate
timeFrame: 24 months
measure: Microbiome composition
timeFrame: 4 months
measure: Concentration of Steroid Hormones
timeFrame: 4 months
measure: Inflammation Index
timeFrame: 4 months
measure: Quality of life (using 30-item Endometriosis Health Profile)
timeFrame: 4 months
measure: Sexual function (using Female Sexual Function Index)
timeFrame: 4 months
measure: Symptomatology severity (using Numeric Rating Scale)
timeFrame: 4 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References: