NCT03687021UnknownEarly Phase 1
Clinical Study on the Impact of Route of Administration of Progesterone and Endometriosis on Endometrial Receptivity
Peking Union Medical College Hospital1 site in 1 country35 target enrollmentStarted: October 10, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- endometrial receptivity measured by pathology
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients with medical complications
Arms & Interventions
Intramuscular progesterone
Experimental
Intramuscular progestin(20mg)
Intervention: Progesterone (Drug)
vaginal progesterone
Experimental
vaginal progestin (90mg)
Intervention: Progesterone (Drug)
oral progesterone
Experimental
oral progestin(40mg)
Intervention: Progesterone (Drug)
Outcomes
Primary Outcomes
endometrial receptivity measured by pathology
Time Frame: 3 months
35 samples will be measured.
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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