The Temporo-spatial Dynamics of Genital Tract Microbiota

NCT03363828 | Completed

• 1 other identifier: 1-10-72-345-15
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• Rate of ascending infection/sharing of bacteria in the genital tract

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

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

Secondary Outcomes (4)

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

  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.

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

  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.

• Number of participants with a Clinical pregnancy

  7-9 weeks after inclusion.

• Number of participants with a Live birth

  36-42 weeks after inclusion

Study Arms (2)

Normal microbiota

Based on qPCR and Next gen sequencing

Abnormal microbiota

Based on qPCR and Next gen sequencing

Drug: Estrofem

Interventions

Estrofem DRUG

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

Abnormal microbiota

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Infertile couples attending IVF treatment and referred to a segmentation protocol.

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Peter Humaidan: lead
• Statens Serum Institut: collaborator

Study Sites (2)

The Fertility Clinic Skive

Skive, 7800, Denmark

Location

The Fertility Clinic, Regional Hospital of Skive

Skive, 7800, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal, cervical and endometrial. Also semen of patients with male partner.

MeSH Terms

Conditions

Infertility, Female

Interventions

estradiol, estriol drug combination

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: December 6, 2017
• Study Start: October 1, 2017
• Primary Completion: September 23, 2019
• Study Completion: January 8, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

DK (2)