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| Name | Class |
|---|---|
| Université Catholique de Louvain | OTHER |
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain | OTHER |
| University of Edinburgh | OTHER |
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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:
Researchers will compare two groups:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-Inflammatory Diet | Experimental | Patients 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the intervention | Adherence to the intervention using 24 hour recall. | 3 months |
| Fertilisation rate | Fertilisation rate per aspirated oocyte retrieved. Defined as the appearance of 2 pronuclei (PN) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola Vigano', PhD | Contact | +390255034302 | paola.vigano@policlinico.mi.it | |
| Marco Reschini, MSc | Contact | +390255034303 | marco.reschini@policlinico.mi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41436256 | Derived | 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. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM |
| UNKNOWN |
| UNIWERSYTET MEDYCZNY W LUBLINIE | UNKNOWN |
| SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET | UNKNOWN |
| University College Cork | OTHER |
| Endometriosis UK | OTHER |
| Wageningen University | OTHER |
| Endometriose Stichting | UNKNOWN |
| Belgian Volition SRL | UNKNOWN |
| ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10 | UNKNOWN |
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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.
| The day after oocyte retrieval |
| Embryo quality | Good quality blastocysts according to Gardner classification | 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. | 12 months |
| Miscarriage rate | Spontaneous or planned abortions. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 4 months |
| D000091662 | Genital Diseases |