The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Subfertility; Infertility

Treatments: Other: 3 Sampling points

Study type: Observational

Funder types: Other

Identifiers

NCT03105453

2016/220

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Study arm

Description:

Women in the study arm will undergo microbiome samplings described in the interventions section (3 sampling points)

Treatment:

Other: 3 Sampling points