Endometrial Receptivity Profile in Patients With Endometrial Proliferation Defects

Completed

• Conditions: Endometrial Dysfunction
• Interventions: Other: Estradiol Valerate, Progesterone in Oil, Leuprolide

• Registration Number: NCT02406690
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Study Start: 2015-07-31
• Primary Completion: 2015-09-17
• Study Completion: 2015-09-17
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	Estradiol Valerate, Progesterone in Oil, Leuprolide	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.
Control Group	Estradiol Valerate, Progesterone in Oil, Leuprolide	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.

Primary Outcome Measures

Name	Time	Method
To determine the differences that may exist in transcriptome, methylome, and estrogen receptor binding between case and control groups	One year

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States