Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-24

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

NCT07090096

Endometriosis

NOT_YET_RECRUITING NA

Pain in Endometriosis And the Relation to Lifestyle

NCT06332560

Endometriosis Adenomyosis

RECRUITING NA

Predicting Endometrial Receptivity for Optimal Reproductive Management

NCT04107129

Infertility, Female Endometriosis

COMPLETED

Danazol Treatment in Endometriosis Women Before IVF

NCT01779232

Endometriosis Ovarian Cysts Infertility

COMPLETED PHASE4

Dienogest Versus GnRH-a Pre-treatment in Women With Endometriosis Undergoing IVF

NCT03142035

Endometriosis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anti-Inflammatory Diet

Patients will follow a 12-week anti-inflammatory diet, followed by the standard IVF treatment protocol.

Group Type EXPERIMENTAL

anti-inflammatory diet

Intervention Type DIETARY_SUPPLEMENT

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

Controls

Patients will undergo the standard IVF treatment protocol without any dietary intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anti-inflammatory diet

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No