The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

NCT ID: NCT03105453

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-11-02

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.

Conditions

Infertility; Subfertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study arm

Women in the study arm will undergo microbiome samplings described in the interventions section (3 sampling points)

3 Sampling points

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Blockeel Christophe

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christophe Blockeel, PhD

Role: STUDY_DIRECTOR

Clinical head

Julie Bussche, Msc

Role: PRINCIPAL_INVESTIGATOR

Research collaborator

Locations

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Countries

Belgium

Related Links

http://www.brusselsivf.be/

Principal research site

Other Identifiers

2016/220

Identifier Type: -

Identifier Source: org_study_id