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NCT Number: NCT06885125

Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

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.

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Key information

Conditions

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

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adherence to the intervention

    Time frame: 3 months

    Adherence to the intervention using 24 hour recall.

  2. Fertilisation rate

    Time frame: The day after oocyte retrieval

    Fertilisation rate per aspirated oocyte retrieved. Defined as the appearance of 2 pronuclei (PN)

  3. Embryo quality

    Time frame: Up to six days after oocyte pick-up

    Good quality blastocysts according to Gardner classification

  4. Cumulative pregnancy rates

    Time frame: 12 months

    All clinical pregnancies achieved by IVF, including the transfer of fresh embryos and all cryopreserved-thawed embryos from the stimulation cycle.

  5. Miscarriage rate

    Time frame: 24 months

    Spontaneous or planned abortions.

  6. Cumulative Live Birth Rate

    Time frame: 24 months

    All live birth achieved by IVF, including the transfer of fresh embryos and all cryopreserved-thawed embryos from the stimulation cycle.

  7. Microbiome composition

    Time frame: 4 months

    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.

  8. Concentration of Steroid Hormones

    Time frame: 4 months

    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.

  9. Inflammation Index

    Time frame: 4 months

    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.

  10. Quality of life (using 30-item Endometriosis Health Profile)

    Time frame: 4 months

    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.

  11. Sexual function (using Female Sexual Function Index)

    Time frame: 4 months

    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.

  12. Symptomatology severity (using Numeric Rating Scale)

    Time frame: 4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Reschini, MSc

CONTACT

[email protected]

+390255034303

Paola Vigano', PhD

CONTACT

[email protected]

+390255034302

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10
  • Belgian Volition SRL
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • Endometriose Stichting
  • Endometriosis UK
  • STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
  • SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET
  • UNIWERSYTET MEDYCZNY W LUBLINIE
  • University College Cork
  • University of Edinburgh
  • Université Catholique de Louvain
  • Wageningen University

Registry information

Official study title

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

Acronym: DANTE

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 20, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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