The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

Universitair Ziekenhuis Brussel300 enrolled

Overview

To assess the impact of the female genital microbiome on ART outcome.

The main objective of this study is to learn more about which microbial spectra are negatively or positively impacting IVF pregnancy outcome. This information is needed before proceeding to the next step in which an adaptation of the microbiome can be attempted to improve IVF outcome. The study is expected to shed light over the possible influence of the microbiome on causes for subfertility, endometrial receptivity and obstetrical complications. A diagnostic link may be found with entities that are often unexplained today, e.g. (recurrent) miscarriage and repeated implantation failure.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Infertility Subfertility

Interventions

3 Sampling pointsOTHER

When entering the in-vitro fertilization/intracytoplasmatic sperm injection 4 samples will be harvested: a rectal swab, a cervical swab, a vaginal swab and an intra-uterine sample using an empty embryo catheter. After the ovarian stimulation treatment, the same patients will be sampled two more times: once at the moment of oocyte retrieval (rectal, cervical, vaginal and intra-uterine samples) and again just before the embryo transfer (at this stage, the embryo culture medium will be harvested, as well as an intra-uterine sample using the tip of an empty embryo inner catheter before the embryo transfer and a rectal sample)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Caucasian women 2. Women undergoing an in-vitro fertilization cycle (for the first or second time) 3. Single embryo transfer 4. Day 5 embryo transfer 5. Gonadotropin-releasing hormone antagonist 6. Anti-mullerian hormone \> 0,69 and \< 3,5 µg/L 7. Body mass index ≤ 30 kg/m2 8. Signed informed consent Exclusion Criteria: 1. Women suffering of chronic diseases which may impair pregnancy outcome (e.g. diabetes, chronic renal disease). 2. Antibiotics within 3 weeks of sampling 3. Surgical sperm retrieval 4. In-vitro maturation 5. Preimplantation genetic diagnosis 6. Grade 3 or 4 endometriosis 7. Patients unable to comprehend the investigational nature of the proposed study

Locations (1)

Universitair Ziekenhuis Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

Clinical pregnancy

To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART

Time frame: 7 weeks

Secondary Outcomes

Baseline microbiome profile

Descriptive analysis of the microbiome present in women suffering of infertility

Time frame: 1 week

Variation of microbiome profile during assisted reproductive technologies

Descriptive analysis of the microbiome present in women suffering of infertility according to the assisted reproductive technologies cycle stage

Time frame: 5 weeks

Microbiome profile of the embryo culture

Descriptive analysis of the microbiome present in the embryo culture on the day of embryo transfer

Time frame: 1 week

Live birth

To determine if there Is there a association between the microbiome profile and pregnancy outcome after assisted reproductive technologies

Time frame: 43 weeks

Data from ClinicalTrials.gov

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