FertilityNCT04323683
The Effect of Progesterone on Human Endometrium
An observational study of Fertility, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study evaluates the relationship between progesterone levels and endometrial gene expression Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Microarray
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Fertile women
Who may be able to join
- Ages 18-35, regular menstrual cycles, the cycle length between 25 and 35 days, body mass index (BMI) between 18 - 25
Who cannot join
- History of infertility, history of pelvic pain or/and endometriosis, history of pelvic mass, history of hormonal therapy in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Fertility
- Being tested
- Microarray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroarrayGenetic
High throughput technique for determining global gene expression of the condition of interest
| Study group | Role | What they receive |
|---|---|---|
| Low progesterone | Women with progesterone level below 15 ng/ml Receives: Genetic: Microarray | |
| Normal progesterone | Women with progesterone level above 15 ng/ml Receives: Genetic: Microarray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentially expressed genes between women with low and normal progesterone
Fold-change and p-value were used to determine differentially expressed genes using Partek software
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Feb 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Maalouf, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323683
- Sponsor's protocol ID
- 13/EM/0277
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progesterone Levels on Human Endometrial Transcriptomics During the Implantation Window
- ClinicalTrials.gov ID
- NCT04323683
- Acronym / sponsor ID
- 13/EM/0277
- Conditions
- Fertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the relationship between progesterone levels and endometrial gene expression
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low progesterone | – | Genetic: MicroarrayWomen with progesterone level below 15 ng/ml |
| Normal progesterone | – | Genetic: MicroarrayWomen with progesterone level above 15 ng/ml |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Fertile women
Key inclusion criteria (1 listed)
- Ages 18-35, regular menstrual cycles, the cycle length between 25 and 35 days, body mass index (BMI) between 18 - 25
Key exclusion criteria (1 listed)
- History of infertility, history of pelvic pain or/and endometriosis, history of pelvic mass, history of hormonal therapy in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroarrayHigh throughput technique for determining global gene expression of the condition of interest | Genetic | Low progesterone, Normal progesterone |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentially expressed genes between women with low and normal progesterone (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.