The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

Study Overview
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Brief Summary
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To assess the impact of the female genital microbiome on ART outcome.

Detailed Description
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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.

Official Title
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The Microbiome in Subfertility and Assisted Reproductive Technologies

Conditions
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Infertility, Subfertility

Intervention / Treatment
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* Other: 3 Sampling points


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study arm<br>Women in the study arm will undergo microbiome samplings described in the interventions section (3 sampling points) | Other: 3 Sampling points<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline microbiome profile | Descriptive analysis of the microbiome present in women suffering of infertility | 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 | 5 weeks | 
| Microbiome profile of the embryo culture | Descriptive analysis of the microbiome present in the embryo culture on the day of embryo transfer | 1 week | 
| Live birth | To determine if there Is there a association between the microbiome profile and pregnancy outcome after assisted reproductive technologies | 43 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assisted reproductive technologies, Microbiome