Asherman's SyndromeNCT06450301
Senescent Endometrial Cells in Patients With Thin Endometrial Lining
An observational study of Asherman's Syndrome and Thin Endometrial Lining, run by Trio Fertility at 1 site in Canada.
Trial summary
The goal of this observational study is to determine if thin endometrial lining that is unresponsive to estrogen might be associated with the presence of senescent cells in patients following long-term use of oral contraceptives. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asherman's Syndrome, Thin Endometrial Lining, Cell Senescence
- What is being tested?
- Endometrial Biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: We intend to recruit 30 patients following long-term use of oral contraceptives with known thin endometrial lining (less than 7mm, confirmed in at least two cycles and unresponsive to estrogen-induced growth). We will also recruit 20 women with Asherman's syndrome following D\&C. We will ask each woman to undergo an endometrial biopsy as part of the study. As a control group, we will recruit 50 patients already scheduled to undergo an endometrial biopsy for infertility management (EMMA testing, endometrial scratching for IVF cycles). Endometrial biopsies are standard procedures during infertility investigations. In some cases, we may be able to access archived endometrial samples from women in the control group who agree to participate and who have already had an endometrial biopsy.
Who may be able to join
- Age 18-39
- BMI - up to 35
- Thin endometrium after OCP use
- Asherman's syndrome
- Women already undergoing endometrial biopsy for infertility testing (eg. EMMA testing)
- Women with archived endometrial biopsy samples
Who cannot join
- Women with systemic disease (Rheumatic disease, DM)
- Women with coagulopathies
- Women with active pelvic inflammatory process
- Uterine anomalies
- Pregnant women
- Any hormonal contraception use or IUD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Trio Fertility
Toronto, Ontario, M5G 2K4
Robert. F. Casper, Dr., 416-506-0804 ext. 3228, casper@lunenfeld.ca
Yasaman Sadeghi, M.Sc., 416-506-0804 ext. 2268, yasamans@triofertility.com
About this study
Official title: Is Thin Endometrial Lining Associated With Senescent Endometrial Cells
The goal of this observational study is to determine if thin endometrial lining that is unresponsive to estrogen might be associated with the presence of senescent cells in patients following long-term use of oral contraceptives. The main question it aims to answer is:
Are there any senescent cells present in thin endometrial lining?
During the luteal phase of the cycle, participants will will undergo:
- Gynecologic US to measure the endometrial lining thickness and pattern.
- Endometrial biopsy with Pipelle catheter
Read the detailed description
The investigators hypothesized that senescent cells in the endometrium may be the cause of the failure of thin endometrium to respond to normal growth stimuli such as estrogen.
The outcome that research team anticipate to measure is the percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.
- Being tested
- Endometrial Biopsy
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial BiopsyProcedure or surgery
An endometrial biopsy is the removal of a small piece of tissue from the endometrium, which is the lining of the uterus. Endometrial biopsies are commonly done to check for the window of implantation, to determine ovulation or for enhancing implantation (procedure called endometrial scratching). For this purpose, we will use a "Pipelle" catheter. This procedure is very common in gynecologic practice and
generally considered safe. In most of the cases this procedure is indicated for evaluation of irregular vaginal bleeding, vaginal bleeding in post-menopausal women and for infertility related problems (recurrent implantation failures for example).
| Study group | Role | What they receive |
|---|---|---|
| Thin endometrial lining | Patients following long-term use of oral contraceptives with known thin endometrial lining (less than 7mm, confirmed in at least two cycles and unresponsive to estrogen-induced growth).
We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase. Receives: Procedure: Endometrial Biopsy | |
| Asherman's syndrome | Patients with Asherman's syndrome following Dilation and curettage (D\&C). We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase. Receives: Procedure: Endometrial Biopsy | |
| Control | Patients already scheduled to undergo an endometrial biopsy for infertility management.
We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase. In some cases, we may be able to access archived endometrial samples from women in the control group who agree to participate and who have already had an endometrial biopsy. Receives: Procedure: Endometrial Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Senescent cells presence
Percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start11 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asherman's SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trio Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert F. Casper, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450301
- Sponsor's protocol ID
- 3533
- Status last verified
- Sep 2026
- First submitted
- 28 May 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Thin Endometrial Lining Associated With Senescent Endometrial Cells
- ClinicalTrials.gov ID
- NCT06450301
- Acronym / sponsor ID
- 3533
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Trio FertilityUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Jun 2024 (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.
The goal of this observational study is to determine if thin endometrial lining that is unresponsive to estrogen might be associated with the presence of senescent cells in patients following long-term use of oral contraceptives. The main question it aims to answer is:
Are there any senescent cells present in thin endometrial lining?
During the luteal phase of the cycle, participants will will undergo:
- Gynecologic US to measure the endometrial lining thickness and pattern.
- Endometrial biopsy with Pipelle catheter
Detailed description
The investigators hypothesized that senescent cells in the endometrium may be the cause of the failure of thin endometrium to respond to normal growth stimuli such as estrogen.
The outcome that research team anticipate to measure is the percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thin endometrial lining | – | Procedure: Endometrial BiopsyPatients following long-term use of oral contraceptives with known thin endometrial lining (less than 7mm, confirmed in at least two cycles and unresponsive to estrogen-induced growth). We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase. |
| Asherman's syndrome | – | Procedure: Endometrial BiopsyPatients with Asherman's syndrome following Dilation and curettage (D\&C). We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase. |
| Control | – | Procedure: Endometrial BiopsyPatients already scheduled to undergo an endometrial biopsy for infertility management. We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase. In some cases, we may be able to access archived endometrial samples from women in the control group who agree to participate and who have already had an endometrial biopsy. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We intend to recruit 30 patients following long-term use of oral contraceptives with known thin endometrial lining (less than 7mm, confirmed in at least two cycles and unresponsive to estrogen-induced growth). We will also recruit 20 women with Asherman's syndrome following D\&C. We will ask each woman to undergo an endometrial biopsy as part of the study. As a control group, we will recruit 50 patients already scheduled to undergo an endometrial biopsy for infertility management (EMMA testing, endometrial scratching for IVF cycles). Endometrial biopsies are standard procedures during infertility investigations. In some cases, we may be able to access archived endometrial samples from women in the control group who agree to participate and who have already had an endometrial biopsy.
Key inclusion criteria (6 listed)
- Age 18-39
- BMI - up to 35
- Thin endometrium after OCP use
- Asherman's syndrome
- Women already undergoing endometrial biopsy for infertility testing (eg. EMMA testing)
Key exclusion criteria (6 listed)
- Women with systemic disease (Rheumatic disease, DM)
- Women with coagulopathies
- Women with active pelvic inflammatory process
- Uterine anomalies
- Pregnant women
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 |
|---|---|---|
| Endometrial BiopsyAn endometrial biopsy is the removal of a small piece of tissue from the endometrium, which is the lining of the uterus. Endometrial biopsies are commonly done to check for the window of implantation, to determine ovulation or for enhancing implantation (procedure called endometrial scratching). For this purpose, we will use a "Pipelle" catheter. This procedure is very common in gynecologic practice and generally considered safe. In most of the cases this procedure is indicated for evaluation of irregular vaginal bleeding, vaginal bleeding in post-menopausal women and for infertility related problems (recurrent implantation failures for example). | Procedure or surgery | Asherman's syndrome, Control, Thin endometrial lining |
Primary outcome
Senescent cells presence
Time frame: Through study completion, an average of 3 years.
Percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asherman's Syndrome and Thin Endometrial Lining, run by Trio Fertility at 1 site in Canada.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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 Canada. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Senescent cells presence (time frame: Through study completion, an average of 3 years.). 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 3 Nov 2026.