NCT02219425

Brief Summary

The aim of this study is to evaluate the gene expression of the endometrium after an endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

July 11, 2014

Last Update Submit

January 29, 2017

Conditions

Infertility

Keywords

InfertilityEndometriumEndometrial biopsyGene expression

Outcome Measures

Primary Outcomes (1)

  • Gene Expression of the Endometrium after an endometrial biopsy

    An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7. Endometrial tissue is analysed for changes in gene expression profile of various chemokines and cytokines using RNA Sequencing technology

    1 month between each biopsy

Study Arms (1)

endometrial biopsy

OTHER
Procedure: endometrial biopsy

Interventions

endometrial biopsyPROCEDURE
Also known as: Pipelle de Cornier
endometrial biopsy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fertile women
  • Age: 18-40 years
  • BMI: 18-32
  • Regular menstrual cycle
  • No use of hormonal contraceptives or IUD the last 3 months

You may not qualify if:

  • Patients in need of a interpreter
  • Suspected intrauterine abnormalities
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic Horsens Hospital

Horsens, Denmark

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Axel Forman, MD, DMsc

    Departement of Gynaecology and Obstetrics, Aarhus University

    STUDY DIRECTOR

  • Mia Steengaard Olesen, MD

    Fertility Clinic Horsens Hospital, Aarhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

August 18, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 31, 2017

Record last verified: 2016-08

Locations

DK(1)