NCT02458404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

1.8 years

First QC Date

March 31, 2015

Last Update Submit

November 6, 2019

Conditions

Luteal Phase Defect

Outcome Measures

Primary Outcomes (3)

  • Endometrial thickness in millimeters as assessed by transvaginal ultrasound

    1. Participants will undergo 3 transvaginal ultrasounds. Endometrial thickness will be recorded. 2. 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

  • 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

  • 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 Outcomes (2)

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

    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

    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

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy human subjects

You may qualify if:

  • Regular menstrual cycles
  • Age 18-50
  • Normal Baseline ultrasound
  • No intra-uterine procedures in prior 90 days

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (1)

  • 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.

    PMID: 32613240DERIVED

Study Officials

  • Richard T Scott, MD, HCLD

    RMA of NJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

June 1, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2017

Study Completion

June 1, 2019

Last Updated

November 7, 2019

Record last verified: 2019-11

Locations

US(1)