The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)
Study Details
Study Description
Brief Summary
To assess the impact of the female genital microbiome on ART outcome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study arm Women in the study arm will undergo microbiome samplings described in the interventions section (3 sampling points) |
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)
|
Outcome Measures
Primary Outcome Measures
- Clinical pregnancy [7 weeks]
To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Caucasian women
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Women undergoing an in-vitro fertilization cycle (for the first or second time)
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Single embryo transfer
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Day 5 embryo transfer
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Gonadotropin-releasing hormone antagonist
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Anti-mullerian hormone > 0,69 and < 3,5 µg/L
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Body mass index ≤ 30 kg/m2
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Signed informed consent
Exclusion Criteria:
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Women suffering of chronic diseases which may impair pregnancy outcome (e.g. diabetes, chronic renal disease).
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Antibiotics within 3 weeks of sampling
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Surgical sperm retrieval
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In-vitro maturation
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Preimplantation genetic diagnosis
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Grade 3 or 4 endometriosis
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Patients unable to comprehend the investigational nature of the proposed study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitair Ziekenhuis Brussel | Brussels | Belgium | 1090 |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
- Study Director: Christophe Blockeel, PhD, Clinical head
- Principal Investigator: Julie Bussche, Msc, Research collaborator
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2016/220