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Effects of Varied Estrogen Doses on Endometrial Receptivity

Information source: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Luteal Phase Defect

Intervention: Estradiol Valerate (Drug); Progesterone (Drug); Leuprolide acetate (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Reproductive Medicine Associates of New Jersey

Official(s) and/or principal investigator(s):
Richard T Scott, MD, HCLD, Principal Investigator, Affiliation: RMA of NJ

Overall contact:
Christine V Reda, BSN,RN, Phone: 973-656-2841, Email: clinicalresearchteam@rmanj.com

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.

Clinical Details

Official title: Effects of Varied Estrogen Doses on Endometrial Receptivity

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Endometrial thickness in millimeters as assessed by transvaginal ultrasound

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

Secondary outcome:

Peak and trough estrogen and progesterone levels as assessed by peripheral phlebotomy

Uterine microbiome characterization by microbiota presence and prevalence as assessed after uterine aspiration

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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Christine V Reda, BSN,RN, Phone: 973-656-2841, Email: clinicalresearchteam@rmanj.com

Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey 07920, United States; Recruiting
Christine V Reda, BSN, RN, Phone: 973-656-2841, Email: clinicalresearchteam@rmanj.com
Talia Metzgar, RN, Phone: 973-656-2841, Email: clinicalresearchteam@rmanj.com
Additional Information

Starting date: March 2015
Last updated: May 27, 2015

Page last updated: August 23, 2015

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