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NCT Number: NCT03363828

The Temporo-spatial Dynamics of Genital Tract Microbiota

The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the semen to the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments. Furthermore, cervical mucus will be obtained in order to test for immunological, microbiological and mechanical properties that may be involved in ascending infection. Finally, the study aim to characterize the temporal changes in the vaginal microbiota during estrogenic treatment with Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Fertility Clinic Skive, Skive, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients in IVF Freeze-all/segmentation treatment protocol.
  • Written informed consent.

Exclusion criteria

  • Uterine malformations
  • HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
  • Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)

Treatment and study plan

Estrofem

Drug

Patients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment

Primary outcomes

  1. Rate of ascending infection/sharing of bacteria in the genital tract

    Time frame: This outcome data is measured at the day of oocyte retrieval.

    Seminal, vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.

Secondary outcomes

  1. Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances

    Time frame: Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.

    Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer.

  2. qPCR to assess the vaginal microbiota. I.e. a quantitative measure Copies/mL.

    Time frame: Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.

    Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer.

  3. Number of participants with a Clinical pregnancy

    Time frame: 7-9 weeks after inclusion.

    Tested by clinical pregnancy scan by ultrasound in week 7-9

  4. Number of participants with a Live birth

    Time frame: 36-42 weeks after inclusion

    Tested by self-reported schemes

Sponsors and collaborators

Lead sponsor

Peter Humaidan

Other

Collaborators

  • Statens Serum Institut

Registry information

Official study title

The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in IVF-Freeze All Patients Treated With Estradiol

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Dec 6, 2017
Registry last updated
Feb 9, 2021

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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