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Completed

NCT Number: NCT03105453

The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

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

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Key information

Conditions

Infertility Genital Diseases Subfertility Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Clinical pregnancy

    Time frame: 7 weeks

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

Secondary outcomes

  1. Baseline microbiome profile

    Time frame: 1 week

    Descriptive analysis of the microbiome present in women suffering of infertility

  2. Variation of microbiome profile during assisted reproductive technologies

    Time frame: 5 weeks

    Descriptive analysis of the microbiome present in women suffering of infertility according to the assisted reproductive technologies cycle stage

  3. Microbiome profile of the embryo culture

    Time frame: 1 week

    Descriptive analysis of the microbiome present in the embryo culture on the day of embryo transfer

  4. Live birth

    Time frame: 43 weeks

    To determine if there Is there a association between the microbiome profile and pregnancy outcome after assisted reproductive technologies

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

The Microbiome in Subfertility and Assisted Reproductive Technologies

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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