The Temporo-spatial Dynamics of Genital Tract Microbiota

P

Peter Humaidan

Status

Completed

Conditions

Infertility, Female

Treatments

Drug: Estrofem

Study type

Observational

Funder types

Other

Identifiers

NCT03363828
1-10-72-345-15

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.)

Trial design

27 participants in 2 patient groups

Normal microbiota
Description:
Based on qPCR and Next gen sequencing
Abnormal microbiota
Description:
Based on qPCR and Next gen sequencing
Treatment:
Drug: Estrofem

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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