NCT04323683

Brief Summary

This study evaluates the relationship between progesterone levels and endometrial gene expression

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

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

February 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 24, 2020

Last Update Submit

March 25, 2020

Conditions

Fertility

Outcome Measures

Primary Outcomes (1)

  • 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

    2 months

Study Arms (2)

Low progesterone

Women with progesterone level below 15 ng/ml

Genetic: Microarray

Normal progesterone

Women with progesterone level above 15 ng/ml

Genetic: Microarray

Interventions

MicroarrayGENETIC

High throughput technique for determining global gene expression of the condition of interest

Low progesteroneNormal progesterone

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Fertile women

You may qualify if:

  • Ages 18-35, regular menstrual cycles, the cycle length between 25 and 35 days, body mass index (BMI) between 18 - 25

You may not qualify if:

  • History of infertility, history of pelvic pain or/and endometriosis, history of pelvic mass, history of hormonal therapy in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's medical center

Nottingham, NG7 2UH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA obtained from endometrium

MeSH Terms

Interventions

Gene Expression Profiling

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Course Director MMedSci Assisted Reproduction Technology, Faculty of Medicine & Health Sciences

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

February 1, 2019

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)