Infertility, Subfertility
Conditions
Keywords
Assisted reproductive technologies, Microbiome
Brief 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.
Interventions
OTHER3 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)
Sponsors
Universitair Ziekenhuis Brussel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 7 weeks | To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline microbiome profile | 1 week | Descriptive analysis of the microbiome present in women suffering of infertility |
| Variation of microbiome profile during assisted reproductive technologies | 5 weeks | Descriptive analysis of the microbiome present in women suffering of infertility according to the assisted reproductive technologies cycle stage |
| Microbiome profile of the embryo culture | 1 week | Descriptive analysis of the microbiome present in the embryo culture on the day of embryo transfer |
| Live birth | 43 weeks | To determine if there Is there a association between the microbiome profile and pregnancy outcome after assisted reproductive technologies |
Countries
Belgium
Outcome results
None listed