NCT03105453

The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

The Microbiome in Subfertility and Assisted Reproductive Technologies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Infertility
• Subfertility

Interventions

Type	Name	Description
OTHER	3 Sampling points	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)

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-11-02
• Completion: 2020-11-02
• First posted: 2017-04-10
• Last updated: 2020-11-03

Locations

1 site across 1 country: Belgium