The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

Infertility Clinical Trial

Official title:

The Microbiome in Subfertility and Assisted Reproductive Technologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105453
• Other study ID #: 2016/220
• Status: Completed
• Start date: September 2016
• Est. completion date: November 2, 2020

Study information

• Verified date: November 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Subfertility

Intervention

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)

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART	7 weeks
Secondary	Baseline microbiome profile	Descriptive analysis of the microbiome present in women suffering of infertility	1 week
Secondary	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
Secondary	Microbiome profile of the embryo culture	Descriptive analysis of the microbiome present in the embryo culture on the day of embryo transfer	1 week
Secondary	Live birth	To determine if there Is there a association between the microbiome profile and pregnancy outcome after assisted reproductive technologies	43 weeks

External Links

•   Principal research site