The Temporo-spatial Dynamics of Genital Tract Microbiota

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363828
• Other study ID #: 1-10-72-345-15
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: January 8, 2021

Study information

• Verified date: February 2021
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 8, 2021
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
Denmark	The Fertility Clinic Skive	Skive
Denmark	The Fertility Clinic, Regional Hospital of Skive	Skive

Sponsors (2)

Lead Sponsor	Collaborator
Peter Humaidan	Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances	Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer.	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.
Secondary	qPCR to assess the vaginal microbiota. I.e. a quantitative measure Copies/mL.	Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer.	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.
Secondary	Number of participants with a Clinical pregnancy	Tested by clinical pregnancy scan by ultrasound in week 7-9	7-9 weeks after inclusion.
Secondary	Number of participants with a Live birth	Tested by self-reported schemes	36-42 weeks after inclusion