Randomized Controlled Study on the Effect of a DietAry interveNtion in Ameliorating fertiliTy Parameters in Women With endomEtriosis Undergoing IVF (The DANTE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Inadequate ovarian response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Anti-Inflammatory Diet
Patients will follow a 12-week anti-inflammatory diet, followed by the standard IVF treatment protocol.
干预措施: anti-inflammatory diet (Dietary Supplement)
Controls
Patients will undergo the standard IVF treatment protocol without any dietary intervention.
结局指标
主要结局
Inadequate ovarian response
时间窗: 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.
次要结局
- 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)
- Cumulative Live Birth Rate(24 months)
- Microbiome composition(4 months)
- Concentration of Steroid Hormones(4 months)
- Inflammation Index(4 months)
- Quality of life (using 30-item Endometriosis Health Profile)(4 months)
- Sexual function (using Female Sexual Function Index)(4 months)
- Symptomatology severity (using Numeric Rating Scale)(4 months)