The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

NCT03105453 | Completed

• 1 other identifier: 2016/220
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility; Subfertility

Keywords

Assisted reproductive technologies; Microbiome

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy

  To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART

  7 weeks

Secondary Outcomes (4)

• Baseline microbiome profile

  1 week

• Variation of microbiome profile during assisted reproductive technologies

  5 weeks

• Microbiome profile of the embryo culture

  1 week

• Live birth

  43 weeks

Study Arms (1)

Study arm

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

Other: 3 Sampling points

Interventions

3 Sampling points 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)

Study arm

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing in-vitro fertilization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Related Links

• Principal research site

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiome analysis using 16S ribosomal RNA sequencing

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Christophe Blockeel, PhD

  Clinical head

  STUDY DIRECTOR

• Julie Bussche, Msc

  Research collaborator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: April 10, 2017
• Study Start: September 1, 2016
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

BE (1)