The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

The Microbiome in Subfertility and Assisted Reproductive Technologies

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

Study Overview

• Status: Completed
• Conditions: Infertility; Subfertility
• Intervention / Treatment: Other: 3 Sampling points

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing in-vitro fertilization

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Study Director: Christophe Blockeel, PhD, Clinical head; Principal Investigator: Julie Bussche, Msc, Research collaborator

Publications and helpful links

Helpful Links

• Principal research site

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): November 2, 2020

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Microbiome; Assisted reproductive technologies
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2016/220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided