Effects of Varied Estrogen Doses on Endometrial Receptivity

Luteal Phase Defect Clinical Trial

Official title:

Effects of Varied Estrogen Doses on Endometrial Receptivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458404
• Other study ID #: RMA-2014-03
• Status: Completed
• Start date: March 2015
• Est. completion date: June 2019

Study information

• Verified date: November 2019
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2019
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Luteal Phase Defect

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial thickness in millimeters as assessed by transvaginal ultrasound	Participants will undergo 3 transvaginal ultrasounds. Endometrial thickness will be recorded.; Purpose: The serum hormone levels serve as the immunoassays while the endometrial lining serves as the bioassay. This will allow for baseline evaluation of the uterine lining and myometrium as well as monitor biological response to the estrogen and progesterone.	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
Primary	mRNA and protein expression of known markers of secretory transformation as assessed by real time PCR and immunohistochemistry after uterine aspiration and disruption/biops	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
Primary	Endometrial echotexture as assessed by transvaginal ultrasound	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	Peak and trough estrogen and progesterone levels as assessed by peripheral phlebotomy	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
Secondary	Uterine microbiome characterization by microbiota presence and prevalence as assessed after uterine aspiration	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