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Endometrial Receptivity Profile in Patients With Endometrial Proliferation Defects

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ClinicalTrials.gov Identifier: NCT02406690
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Brief Summary:
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.

Condition or disease Intervention/treatment
Endometrial Dysfunction Other: Estradiol Valerate, Progesterone in Oil, Leuprolide

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
Actual Enrollment : 1 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Endometrial Receptivity Profile in Patients With Endometrial Proliferation Defects
Actual Study Start Date : July 31, 2015
Actual Primary Completion Date : September 17, 2015
Actual Study Completion Date : September 17, 2015


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.




Primary Outcome Measures :
  1. To determine the differences that may exist in transcriptome, methylome, and estrogen receptor binding between case and control groups [ Time Frame: One year ]

Biospecimen Retention:   Samples With DNA
One tube of serum (approximately 3.5 mL) will be collected from participant at each visit via venipuncture. An uterine aspiration and endometrial biopsy sample will be taken at Day 6 of Progestrone Adminstration.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406690


Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, Jr., MD, HCLD Reproductive Medicine Associates of New Jersey

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT02406690     History of Changes
Other Study ID Numbers: RMA-2014-04
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Reproductive Medicine Associates of New Jersey:
Endometrial Insufficiency
Endometrial Receptivity

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Leuprolide
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins
Fertility Agents, Female
Fertility Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents