- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323683
The Effect of Progesterone on Human Endometrium
March 25, 2020 updated by: Walid Maalouf, University of Nottingham
The Effect of Progesterone Levels on Human Endometrial Transcriptomics During the Implantation Window
This study evaluates the relationship between progesterone levels and endometrial gene expression
Study Overview
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nottingham, United Kingdom, NG7 2UH
- Queen's Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Fertile women
Description
Inclusion Criteria:
- Ages 18-35, regular menstrual cycles, the cycle length between 25 and 35 days, body mass index (BMI) between 18 - 25
Exclusion Criteria:
- History of infertility, history of pelvic pain or/and endometriosis, history of pelvic mass, history of hormonal therapy in the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Low progesterone
Women with progesterone level below 15 ng/ml
|
High throughput technique for determining global gene expression of the condition of interest
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Normal progesterone
Women with progesterone level above 15 ng/ml
|
High throughput technique for determining global gene expression of the condition of interest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differentially expressed genes between women with low and normal progesterone
Time Frame: 2 months
|
Fold-change and p-value were used to determine differentially expressed genes using Partek software
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2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
March 24, 2020
First Submitted That Met QC Criteria
March 25, 2020
First Posted (Actual)
March 26, 2020
Study Record Updates
Last Update Posted (Actual)
March 26, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 13/EM/0277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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