NCT03687021

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2018

Completed
Last Updated

September 27, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

August 13, 2018

Last Update Submit

September 25, 2018

Conditions

Endometrial Receptivity;RNA; Progesterone

Keywords

endometrial receptivityRNAprogesterone

Outcome Measures

Primary Outcomes (1)

  • endometrial receptivity measured by pathology

    35 samples will be measured.

    3 months

Secondary Outcomes (3)

  • endometrial receptivity measured by immunohisochemistry

    3 months

  • endometrial receptivity measured by Ribose Nucleic Acid （RNA）

    3 months

  • endometrial receptivity measured by scanning electron microscope

    3 months

Study Arms (5)

endometriosis

NO INTERVENTION

tissue biopsy from patients (n=10) with endometriosis

without endometriosis

NO INTERVENTION

tissue biopsy from patients (n=10) without endometriosis

Intramuscular progesterone

EXPERIMENTAL

Intramuscular progestin(20mg)

Drug: Progesterone

vaginal progesterone

EXPERIMENTAL

vaginal progestin (90mg)

Drug: Progesterone

oral progesterone

EXPERIMENTAL

oral progestin(40mg)

Drug: Progesterone

Interventions

ProgesteroneDRUG

Different routes of administration of progesterone; Whether there is endometriosis

Intramuscular progesteroneoral progesteronevaginal progesterone

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients with medical complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

September 27, 2018

Study Start

October 10, 2018

Primary Completion

October 10, 2018

Study Completion

November 10, 2018

Last Updated

September 27, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)