Endometrial Receptivity Profile in Patients With Endometrial Proliferation Defects

November 29, 2017 updated by: Reproductive Medicine Associates of New Jersey
The purpose of this study is to determine the differences that exist in RNA molecules, the biochemical process of methylation, and estrogen receptor binding in patients that have failed to produce adequate endometrium in synthetic embryo transfer cycles when compared to patients whose endometrium thickness is within normal limits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine the differences that may exist in RNA molecules, the biochemical process of methylation, and estrogen receptor binding (this is a group of proteins in the cell that are activated by the hormone estrogen) in patients that have failed to produce adequate endometrium (uterine lining) in synthetic embryo transfer cycles when compared to patients whose endometrium thickness is within normal limits.

Appropriate embryo development and luteal phase (when fertilization and implantation occur) transformation of the endometrium create a small window of opportunity where successful implantation can occur. The interaction between the embryo and the endometrium is complex and poorly understood.

The endometrium, which consists of two layers called the functionalis and basalis, goes through changes during the menstrual cycle. The changes that occur are needed for successful implantation of an embryo. The proliferative phase of the menstrual cycle is primarily governed by estrogen and is responsible for the thickening of the endometrium. Progesterone primarily controls the last half of the menstrual cycle and causes changes which allows for embryo implantation.

Through in vitro fertilization (IVF), the investigators have seen that the correct thickness of endometrium is a marker of successful implantation and ongoing pregnancy, although the reason for this is not entirely clear. In order to better understand the processes that may occur in the endometrium, the investigators are conducting a study which evaluates biochemical markers of those patients who have shown a failure to proliferate during previous synthetic IVF frozen cycles and biochemical markers of control patients who have no known endometrial pathology.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Reproductive Medicine Associates of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone a synthetic endometrial proliferation cycle in preparation for an embryo transfer that were identified as having a proliferative phase defect will serve as the subjects. Normal, healthy patients who are undergoing infertility treatment for single gene disorder, family balancing, or male factor infertility will serve as controls. The study will occur as part of a cryosynthetic preparatory cycle prior to embryo transfer. There will be 10 cases and 10 controls recruited for participation in the study.

Description

Inclusion Criteria for Case Group:

  • Diagnosis of endometrial insufficiency- prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid.

Exclusion Criteria for Case and Control Groups:

  • Any evidence for surgically induced endometrial insufficiency (Asherman's syndrome)
  • Presence of hydrosalpinges that communicate with endometrial cavity

  • 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 estradiol valerate, progesterone in oil, leuprolide acetate
    • Known pregnancy or delivery within the past 6 months
    • Breastfeeding
    • Obesity >35 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case Group
Patients who failed to achieve adequate endometrial lining during a synthetic embryo transfer. This group will undergo a Leuprolide prep cycle using estradiol valerate, progesterone in oil and subsequently undergo an endometrial biopsy and uterine aspiration.
Other: Estradiol Valerate, Progesterone in Oil, Leuprolide
Patients will undergo a Leuprolide endometrial preparatory cycle using estradiol valerate, progesterone in oil and once completed will have a uterine aspiration and biopsy performed.
Control Group
Patients who have achieved an adequate endometrial lining. This group will undergo a Leuprolide prep cycle using estradiol valerate, progesterone in oil and subsequently undergo an endometrial biopsy and uterine aspiration.
Other: Estradiol Valerate, Progesterone in Oil, Leuprolide
Patients will undergo a Leuprolide endometrial preparatory cycle using estradiol valerate, progesterone in oil and once completed will have a uterine aspiration and biopsy performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the differences that may exist in transcriptome, methylome, and estrogen receptor binding between case and control groups
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Richard T Scott, Jr., MD, HCLD, Reproductive Medicine Associates of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 31, 2015

Primary Completion (ACTUAL)

September 17, 2015

Study Completion (ACTUAL)

September 17, 2015

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (ESTIMATE)

April 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMA-2014-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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