Endometrial Receptivity;RNA; ProgesteroneEarly Phase 1NCT03687021
Clinical Study on Endometrial Receptivity
A Early Phase 1 study testing Progesterone in people with Endometrial Receptivity;RNA; Progesterone, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Receptivity;RNA; Progesterone
- What is being tested?
- Progesterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2018to 10 Nov 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Patients with medical complications
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Qi Yu, profssor, 18612671865, yuqi2008001@sina.com
Xi Wang, 13121133350, wangxi2008001@sina.com
About this study
Official title: 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
- Being tested
- Progesterone
- Keywords
- endometrial receptivity, RNA, progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Different routes of administration of progesterone; Whether there is endometriosis
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Progesterone |
| vaginal progesterone | Experimental | vaginal progestin (90mg) Receives: Drug: Progesterone |
| oral progesterone | Experimental | oral progestin(40mg) Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial receptivity measured by pathology
35 samples will be measured.
Measured: 3 months
Secondary outcomes (3)
endometrial receptivity measured by immunohisochemistry
35 samples will be measured
Measured: 3 months
endometrial receptivity measured by Ribose Nucleic Acid （RNA）
35 samples will be measured
Measured: 3 months
endometrial receptivity measured by scanning electron microscope
35 samples will be measured
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start10 Oct 2018 (estimated)
- Primary completion10 Oct 2018 (estimated)
- Study completion10 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Receptivity;RNA; ProgesteroneStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687021
- Sponsor's protocol ID
- yuqi03029
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Impact of Route of Administration of Progesterone and Endometriosis on Endometrial Receptivity
- ClinicalTrials.gov ID
- NCT03687021
- Acronym / sponsor ID
- yuqi03029
- Keywords
- endometrial receptivity, RNA, progesterone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 Oct 2018 (estimated)
- Primary completion
- 10 Oct 2018 (estimated)
- Study completion
- 10 Nov 2018 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: ProgesteroneIntramuscular progestin(20mg) |
| vaginal progesterone | Experimental | Drug: Progesteronevaginal progestin (90mg) |
| oral progesterone | Experimental | Drug: Progesteroneoral progestin(40mg) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with medical complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgesteroneDifferent routes of administration of progesterone; Whether there is endometriosis | Drug | Intramuscular progesterone, oral progesterone, vaginal progesterone |
Primary outcome
endometrial receptivity measured by pathology
Time frame: 3 months
35 samples will be measured.
3 secondary outcomes
endometrial receptivity measured by immunohisochemistry
Time frame: 3 months
endometrial receptivity measured by Ribose Nucleic Acid （RNA）
Time frame: 3 months
endometrial receptivity measured by scanning electron microscope
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Progesterone in people with Endometrial Receptivity;RNA; Progesterone, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial receptivity measured by pathology (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.