Transcriptomic Profile of Endometrium in Different Histological Dating of Natural Cycle

January 9, 2022 updated by: Reproductive & Genetic Hospital of CITIC-Xiangya
At present, the evaluation criterion of endometrial receptivity is controversial. The development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown that the window of implantation (WOI) is displaced in only a quarter of these patients and use of a personalized embryo transfer (pET) on the day designated by ERA improves reproductive performance with higher cost .what is known to the others'population? The morphological changes observed on histology for each specific day after ovulation were described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference of more than 2 days between the histologic dating and actual day after ovulation is considered to be ''out of phase''. But such pET studies according to the Noyes criterion are lacking . The aim of this study is to explore the transcriptomic profile of endometrial receptivity in different histological dating of natural cycle and its clinical application.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Reproductive & Genetic Hospital of Citic-Xiangya

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The inclusion criteria for RIF group were: unexplained repeated implantation failure (RIF) is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers.

The inclusion criteria for control group were: (1) age <35 years; (2) regular menstrual cycles of 24-35 days; (3) baseline follicle- stimulating hormone (FSH) < 9.0 IU/L; (4) endometrial thickness ≥8.0 mm on the day of hCG administration.

Exclusion Criteria:

  • (1) uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus); (2) intrauterine adhesions（moderate - severe）, endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure) (3) history of adverse pregnancy (including spontaneous abortion, stillbirth, and fetal malformation).

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RIF group

According to the histological dating and transcriptomic profile of endometrium of natural cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer .

The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating and transcriptomic profile by endometrial biopsy on 7 days after ovulation. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating and transcriptomic profile were determined according to the pregnancy. outcome of the FET cycle .
Procedure: personal embryo transfer

According to the histological dating and transcriptomic profile of endometrium of natural cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer .

The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating and transcriptomic profile by endometrial biopsy on 7 days after ovulation. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating and transcriptomic profile were determined according to the pregnancy. outcome of the FET cycle .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: at least one intrauterine gestational sac with cardiac action by ultrasound performed 28 days after embryo transfer
clinical pregnancy rate
at least one intrauterine gestational sac with cardiac action by ultrasound performed 28 days after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical pregnancy
Time Frame: 14 days after embryo transfer
Biochemical pregnancy
14 days after embryo transfer

Collaborators and Investigators

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

Sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 17, 2017

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ACTUAL)

March 30, 2018

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (ACTUAL)

July 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYXM-201702

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Infertility, Female

Clinical Trials on personal embryo transfer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe