Clinical Study on Endometrial Receptivity

September 25, 2018 updated by: Peking Union Medical College Hospital

Clinical Study on the Impact of Route of Administration of Progesterone and Endometriosis on Endometrial Receptivity

to explore the differential expression of miRNA in the implantation window of patients with endometriosis and the time of progesterone and route of administration on planting window

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Early Phase 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

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

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 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. The endometriosis group treatment group: Previous laparoscopy or laparotomy confirmed endometriosis;Regular menstruation, no rule vaginal bleeding;Ovarian reserve function is normal.

    control group: Laparoscopic bilateral salpingectomy was performed due to ectopic pregnancy, benign ovarian changes and other reasons, with the exception of endometriosis during the operation.Regular menstruation, no rule vaginal bleeding;Ovarian reserve function is normal

  2. progesterone group Women with hypothalamic amenorrhea or premature ovarian failure;Ages 18-40

Exclusion Criteria:

Patients with medical complications

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: endometriosis
tissue biopsy from patients (n=10) with endometriosis
NO_INTERVENTION: without endometriosis
tissue biopsy from patients (n=10) without endometriosis
EXPERIMENTAL: Intramuscular progesterone
Intramuscular progestin(20mg)
Drug: Progesterone
Different routes of administration of progesterone; Whether there is endometriosis
EXPERIMENTAL: vaginal progesterone
vaginal progestin (90mg)
Drug: Progesterone
Different routes of administration of progesterone; Whether there is endometriosis
EXPERIMENTAL: oral progesterone
oral progestin(40mg)
Drug: Progesterone
Different routes of administration of progesterone; Whether there is endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometrial receptivity measured by pathology
Time Frame: 3 months
35 samples will be measured.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometrial receptivity measured by immunohisochemistry
Time Frame: 3 months
35 samples will be measured
3 months
endometrial receptivity measured by Ribose Nucleic Acid （RNA）
Time Frame: 3 months
35 samples will be measured
3 months
endometrial receptivity measured by scanning electron microscope
Time Frame: 3 months
35 samples will be measured
3 months

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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 (ANTICIPATED)

October 10, 2018

Primary Completion (ANTICIPATED)

October 10, 2018

Study Completion (ANTICIPATED)

November 10, 2018

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (ACTUAL)

September 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yuqi03029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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