Effects of Varied Estrogen Doses on Endometrial Receptivity

NCT ID: NCT02458404

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-06-30

Brief 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.

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.

Conditions

Luteal Phase Defect

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard T Scott, MD, HCLD

Role: PRINCIPAL_INVESTIGATOR

RMA of NJ

Locations

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Countries

United States

References

Osman EK, Wang T, Zhan Y, Juneau CR, Morin SJ, Seli E, Scott RT, Franasiak JM. Varying levels of serum estradiol do not alter the timing of the early endometrial secretory transformation. Hum Reprod. 2020 Jul 1;35(7):1637-1647. doi: 10.1093/humrep/deaa135.

Reference Type: DERIVED

PMID: 32613240 (View on PubMed)

Other Identifiers

RMA-2014-03

Identifier Type: -

Identifier Source: org_study_id