Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

Официальное название

Randomized Controlled Study on the Effect of a DietAry interveNtion in Ameliorating fertiliTy Parameters in Women With endomEtriosis Undergoing IVF (The DANTE Study)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Inadequate ovarian response [Срок оценки: During the oocyte retrieval procedure]

Вторичные конечные точки (12)

• Adherence to the intervention [Срок оценки: 3 months]
• Fertilisation rate [Срок оценки: The day after oocyte retrieval]
• Embryo quality [Срок оценки: Up to six days after oocyte pick-up]
• Cumulative pregnancy rates [Срок оценки: 12 months]
• Miscarriage rate [Срок оценки: 24 months]
• Cumulative Live Birth Rate [Срок оценки: 24 months]
• Microbiome composition [Срок оценки: 4 months]
• Concentration of Steroid Hormones [Срок оценки: 4 months]
• Inflammation Index [Срок оценки: 4 months]
• Quality of life (using 30-item Endometriosis Health Profile) [Срок оценки: 4 months]
• Sexual function (using Female Sexual Function Index) [Срок оценки: 4 months]
• Symptomatology severity (using Numeric Rating Scale) [Срок оценки: 4 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan

Публикации

• 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

Идентификаторы

NCT: NCT06885125 · DANTE Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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