CompletedNot Applicable

Effects of Varied Estrogen Doses on Endometrial Receptivity

United States19 participantsStarted 2015-03

Plain-language summary

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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Endometrial thickness in millimeters as assessed by transvaginal ultrasound

Timeframe: 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

Endometrial echotexture as assessed by transvaginal ultrasound

Trial details

NCT IDNCT02458404

SponsorReproductive Medicine Associates of New Jersey

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-01

View on ClinicalTrials.gov More Luteal Phase Defect trials