The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

Completed

• Conditions: Infertility; Subfertility
• Interventions: Other: 3 Sampling points

• Registration Number: NCT03105453
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-10
• Status Verified: 2020-11
• Primary Completion: 2020-11-02
• Study Completion: 2020-11-02
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study arm	3 Sampling points	Women in the study arm will undergo microbiome samplings described in the interventions section (3 sampling points)

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	7 weeks	To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium