- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458404
Effects of Varied Estrogen Doses on Endometrial Receptivity
November 6, 2019 updated by: Reproductive Medicine Associates of New Jersey
This study will help determine the effect of varied estradiol levels on the uterine lining in healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle.
Study Overview
Status
Completed
Conditions
Detailed Description
Volunteers who wish to participate in the study, will undergo a diagnostic and screening phase to determine their eligibility.
Once eligibility is determined, participants will undergo three, separate "endometrial preparatory cycles".
These cycles will consist of estrogen supplementation to mimic normal, above normal, and highly elevated estradiol levels.
Once supplementation is complete uterine procedures will be done to hopefully determine the effects of the estrogen levels on the uterine lining.
Subcutaneous leuprolide injections, intramuscular estrogen, and progesterone injections will be used to mimic the levels needed.
Blood draws will monitor the needed estradiol and progesterone levels during the injection phase of the cycle.
Once the injection phase is complete, transvaginal ultrasound, uterine aspiration, and endometrial biopsy will be done.
Study Type
Observational
Enrollment (Actual)
19
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
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Reproductive Medicine Associates of New Jersey
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Healthy human subjects
Description
Inclusion Criteria:
- Regular menstrual cycles
- Age 18-50
- Normal Baseline ultrasound
- No intra-uterine procedures in prior 90 days
Exclusion Criteria:
- Any contraindications to undergoing estrogen stimulation of the endometrium
- Age ≥35 years and smoking ≥15 cigarettes per day
- Multiple risk factors for arterial cardiovascular disease (smoking, diabetes, and hypertension)
- Hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Venous thromboembolism (current or history of)
- Known thrombogenic mutations
- Known ischemic heart disease
- History of stroke
- Complicated valvular heart disease (pulmonary hypertension, risk for atrial fibrillation, history of subacute bacterial endocarditis)
- Systemic lupus erythematosus (positive or unknown antiphospholipid antibodies)
- Migraine with aura at any age
- Breast cancer
- Cirrhosis
- Hepatocellular adenoma or malignant hepatoma
- History of undiagnosed abnormal uterine bleeding.
- Allergic reaction to any study drug
- Known pregnancy or delivery within the past 6 months
- Breastfeeding
- Obesity >35 kg/m2
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endometrial thickness in millimeters as assessed by transvaginal ultrasound
Time Frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
|
Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
mRNA and protein expression of known markers of secretory transformation as assessed by real time PCR and immunohistochemistry after uterine aspiration and disruption/biops
Time Frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
Patients will undergo a uterine aspiration and endometrial disruption/biopsy.
These will be analyzed for known markers involved in human reproduction utilizing established molecular biological assessment tools.
In particular markers which will be evaluated will be: LIF, CXCL13, beta 2 integrin, DAF, OPN, and IL15
|
Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
Endometrial echotexture as assessed by transvaginal ultrasound
Time Frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
a. Participants will undergo 3 transvaginal ultrasounds.
Endometrial echotexture will be recorded.
|
Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak and trough estrogen and progesterone levels as assessed by peripheral phlebotomy
Time Frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
Peripheral phlebotomy will be performed in order to determine peak and trough levels of hormones.
|
Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
Uterine microbiome characterization by microbiota presence and prevalence as assessed after uterine aspiration
Time Frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
Patients will undergo a uterine aspiration.
The human microbiome project has revealed important things about the vaginal microbiome, but little is known about the uterine microbiome.
Given the hormonal changes change the pH of the vagina, we will be able to characterize differences in the uterine microbiome with varied estrogen levels.
|
Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard T Scott, MD, HCLD, RMA of NJ
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
March 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
March 31, 2015
First Submitted That Met QC Criteria
May 27, 2015
First Posted (Estimate)
June 1, 2015
Study Record Updates
Last Update Posted (Actual)
November 7, 2019
Last Update Submitted That Met QC Criteria
November 6, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- RMA-2014-03
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.
Clinical Trials on Luteal Phase Defect
-
Instituto BernabeuCompleted
-
National University of MalaysiaCompleted
-
University of ZagrebCompletedLuteal Phase DefectCroatia
-
Centrum Clinic IVF CenterCompletedLuteal Phase Defect | Pregnancy Loss | Assisted Reproduction | Implantation; Placenta | Frozen Embryo | Luteal SupportTurkey
-
Penn State UniversityUnited States Department of Defense; National Institutes of Health (NIH); National...CompletedMenstruation Disturbances | Luteal Phase Defect
-
Penn State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedMenstruation Disturbances | Amenorrhea | Luteal Phase Defect | Oligomenorrhea
-
UMC UtrechtNot yet recruitingPregnancy Related | Fertility Issues | Luteal Phase Defect | Infertility Unexplained
-
University of AthensIaso Maternity Hospital, Athens, GreeceRecruiting
-
Fudan UniversityRecruitingIdiopathic Hypogonadotropic Hypogonadism | Luteal Phase Support | Luteal Phase DeficiencyChina