Quantitative Identification of Implantation Receptivity by Single Cell Transcriptome Analysis

NCT03091023 | Unknown

• 1 other identifier: 1603-IGX-016-CS
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project aims to study the endometrial transcriptome at the single cell level in both endometrial native tissue (biopsies) and endometrial fluid. Basically, the goals are: 1) To use the resolution provided by single-cell RNA-seq to deconvolute real time dynamics in endometrium transcriptome throughout the menstrual cycle from artifacts produced by known population heterogeneity, and 2) To use endometrium fluid to replace endometrium biopsies as signal source to develop a new diagnostic platform to determine the endometrium receptive state which is high resolution and minimally invasive. This study will provide an unprecedented high-resolution characterization of the endometrium cellular hierarchy via whole transcriptome analysis throughout the menstrual stages. These results will lead to a robust definition of stage-defining gene expression signatures and resolve the long-standing inconsistencies originating from bulk tissue studies. The dataset will be further explored via informatics tools to provide biological insights into the dynamics of endometrium and initiate new anchor points for functional studies.

Conditions

Endometrial Receptivity Diagnosis

Keywords

Endometrial receptivity; Transcriptomic; Single cell; Endometrial fluid

Outcome Measures

Primary Outcomes (1)

• Transcriptomic profile analysis of the endometrial samples by RNA sequencing.

  24 months

Study Arms (2)

Natural cycle

ACTIVE COMPARATOR

Endometrial biopsies and endometrial fluid obtained from healthy females throughout the menstrual cycle at each of these stages: Early proliferative (EP; days 0-8), late proliferative (LP; days 9-14), early secretory (ES; days 15-18), mid-secretory or receptive (MS; days 19-23), and late secretory (LS; days 24-30)

Procedure: Endometrial Biopsy and endometrial fluid collection

ERA in HRT cycle

ACTIVE COMPARATOR

Endometrial biopsy and endometrial fluid obtained from woman undergoing to Endometrial Receptivity Analysis (ERA) in a hormonal replacement therapy (HRT) cycle.

Procedure: Endometrial Biopsy and endometrial fluid collection

Interventions

Endometrial Biopsy and endometrial fluid collection PROCEDURE

ERA in HRT cycle; Natural cycle

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women in natural cycle;
• Normal karyotype;
• Negative serologic tests for HIV, HBV, HCV, RPR;
• BMI: 18 - 30 Kg/m2 (both included);
• Women with regular menstrual cycle (3-4/28-30 days).

You may not qualify if:

• Patients who had carried an intrauterine device in the previous 3 months;
• Patients who have taken hormonal contraceptives in the previous 2 months;
• Adnexal or uterine pathologies;
• Polycystic ovary;
• Any unstable disease or medical condition that could interfere with the study or put in risk the health of the patient (evaluated by the principal researcher of the research team);
• Any illness or medical unstable condition.

Sponsors & Collaborators

• Igenomix: lead
• Stanford University: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director IGENOMIX; Gynaecologist IVI Valencia

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: March 27, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share