Infertility of Uterine OriginNCT04045821
Endometrial Rejuvenation Study
A study testing AMD3100, Normal saline and dilation and curettage in people with Infertility of Uterine Origin, run by Reproductive Medicine Associates of New Jersey at 3 sites in United States.
Trial summary
To evaluate the response of the endometrial lining after subcutaneous administration of the medication AMD3100. This medication mobilizes stem cells and will be used in a population of infertile women with a thin endometrium who are undergoing frozen-thawed embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Infertility of Uterine Origin
- What is being tested?
- AMD3100, Normal saline and dilation and curettage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jan 2020to 4 May 2021
- Phase
- Interventional
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients planning to undergo a frozen-thawed embryo transfer cycle using a single euploid blastocyst.
- Patients who have previously undergone at least 2 unsuccessful frozen-thawed embryo transfer cycles, defined as failure to achieve a clinical pregnancy (visualization of intrauterine gestational sac on ultrasound) or a cancelled embryo transfer cycle due to inadequate endometrial thickness.
- Patients with a diagnosis of thin endometrial lining (less than 6 mm maximum thickness) during at least one prior unsuccessful embryo transfer cycle.
- Initiation of the most recent unsuccessful frozen-thawed embryo transfer cycle with a thin endometrial lining must have occurred after January 1, 2017.
Who cannot join
- Fewer than 2 prior unsuccessful frozen-thawed embryo transfer cycles.
- Most recent unsuccessful frozen-thawed embryo transfer prior to January 1, 2017.
- No euploid embryos available for transfer.
- Mullerian anomalies, excluding arcuate uterus
- Submucosal fibroids
- History of uterine surgery, excluding polypectomy, D\&C, and Cesarean section
Show all 10Show fewer
- Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
- Failure of patient to agree to enrollment in study with written consent.
- History of drug sensitivity or adverse reaction to AMD3100 (plerixafor).
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
Reproductive Medicine Associates of Philadelphia
Philadelphia, Pennsylvania, 19107
Reproductive Medicine Associates of Northern California
San Francisco, California, 94105
About this study
Official title: Endometrial Response Following Use of the Stem Cell Mobilizing Agent AMD3100 in a Population of Infertile Women With a Thin Endometrial Lining
To evaluate the response of the endometrial lining after subcutaneous administration of the medication AMD3100. This medication mobilizes stem cells and will be used in a population of infertile women with a thin endometrium who are undergoing frozen-thawed embryo transfer. The investigators will assess associations between response to stem cell mobilization and pregnancy outcomes.
Read the detailed description
This study seeks to help each participant build a better endometrial lining which is suitable to implantation and maintenance of a healthy pregnancy. While animal models demonstrating the effectiveness of stem cell recruitment on improved endometrial thickness and pregnancy outcomes are plentiful, human studies are lacking. The use of stem cells from the peripheral circulation in humans could potentially allow for enhanced endometrial proliferation. The objective of this study is to perform a prospective randomized, controlled trial to evaluate the response of the endometrial lining after subcutaneous administration of AMD3100 (plerixafor). AMD3100 is an immunostimulant used to mobilize hematopoietic stem cells in the bloodstream. This intervention will be studied in a population of infertile women with a thin endometrium who have failed previous embryo transfer cycles and are undergoing a frozen-thawed embryo transfer. This study seeks to evaluate both the endometrial response to stem cell mobilization via AMD3100 as well as pregnancy outcomes.
- Conditions
- Infertility of Uterine Origin
- Being tested
- AMD3100, Normal saline, dilation and curettage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMD3100Drug
Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose
Normal salineDrug
Subjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose
dilation and curettageProcedure or surgery
Also called D&C
all participants will undergo routine D\&C procedure
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients in this arm will not receive the study drug. A placebo of normal saline will be injected subcutaneously and the D\&C procedure will be completed. Receives: Drug: Normal saline; Procedure: dilation and curettage |
| Intervention | Experimental | Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D\&C procedure will be completed. Receives: Drug: AMD3100; Procedure: dilation and curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness
measurement of endometrial thickness
Measured: measured on day prior to progesterone initiation during frozen embryo transfer cycle
Secondary outcomes (4)
number of participants with a chemical pregnancy
defined by a positive bHCG
Measured: 9-11 days post embryo transfer
number of participants with a clinical pregnancy
defined as the presence of an intrauterine gestational sac
Measured: seen as early as 18 days post embryo transfer
number of participants with a live births
number of deliveries resulting from embryo transfer
Measured: typically 9 months from embryo transfer
endometrial volume
measurement of uterine endometrium based on 3D ultrasound
Measured: measured at baseline visit during cycle 1 (one month) and after progesterone initiation during cycle 4 (one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start17 Jan 2020
- Primary completion27 Jan 2021
- Study completion4 May 2021
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility of Uterine OriginStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Hanson, MD, Study director, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045821
- Sponsor's protocol ID
- RMA-2019-02
- Status last verified
- May 2021
- First submitted
- 25 Jul 2019
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Response Following Use of the Stem Cell Mobilizing Agent AMD3100 in a Population of Infertile Women With a Thin Endometrial Lining
- ClinicalTrials.gov ID
- NCT04045821
- Acronym / sponsor ID
- RMA-2019-02
- Conditions
- Infertility of Uterine Origin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 6 Aug 2019 (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 evaluate the response of the endometrial lining after subcutaneous administration of the medication AMD3100. This medication mobilizes stem cells and will be used in a population of infertile women with a thin endometrium who are undergoing frozen-thawed embryo transfer. The investigators will assess associations between response to stem cell mobilization and pregnancy outcomes.
Detailed description
This study seeks to help each participant build a better endometrial lining which is suitable to implantation and maintenance of a healthy pregnancy. While animal models demonstrating the effectiveness of stem cell recruitment on improved endometrial thickness and pregnancy outcomes are plentiful, human studies are lacking. The use of stem cells from the peripheral circulation in humans could potentially allow for enhanced endometrial proliferation. The objective of this study is to perform a prospective randomized, controlled trial to evaluate the response of the endometrial lining after subcutaneous administration of AMD3100 (plerixafor). AMD3100 is an immunostimulant used to mobilize hematopoietic stem cells in the bloodstream. This intervention will be studied in a population of infertile women with a thin endometrium who have failed previous embryo transfer cycles and are undergoing a frozen-thawed embryo transfer. This study seeks to evaluate both the endometrial response to stem cell mobilization via AMD3100 as well as pregnancy outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Normal saline, Procedure: dilation and curettagePatients in this arm will not receive the study drug. A placebo of normal saline will be injected subcutaneously and the D\&C procedure will be completed. |
| Intervention | Experimental | Drug: AMD3100, Procedure: dilation and curettagePatients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D\&C procedure will be completed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients planning to undergo a frozen-thawed embryo transfer cycle using a single euploid blastocyst.
- Patients who have previously undergone at least 2 unsuccessful frozen-thawed embryo transfer cycles, defined as failure to achieve a clinical pregnancy (visualization of intrauterine gestational sac on ultrasound) or a cancelled embryo transfer cycle due to inadequate endometrial thickness.
- Patients with a diagnosis of thin endometrial lining (less than 6 mm maximum thickness) during at least one prior unsuccessful embryo transfer cycle.
- Initiation of the most recent unsuccessful frozen-thawed embryo transfer cycle with a thin endometrial lining must have occurred after January 1, 2017.
Key exclusion criteria (10 listed)
- Fewer than 2 prior unsuccessful frozen-thawed embryo transfer cycles.
- Most recent unsuccessful frozen-thawed embryo transfer prior to January 1, 2017.
- No euploid embryos available for transfer.
- Mullerian anomalies, excluding arcuate uterus
- Submucosal fibroids
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 |
|---|---|---|
| AMD3100Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose | Drug | Intervention |
| Normal salineSubjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose | Drug | Control |
| dilation and curettageAlso: D&Call participants will undergo routine D\&C procedure | Procedure or surgery | Control, Intervention |
Primary outcome
Endometrial thickness
Time frame: measured on day prior to progesterone initiation during frozen embryo transfer cycle
measurement of endometrial thickness
4 secondary outcomes
number of participants with a chemical pregnancy
Time frame: 9-11 days post embryo transfer
number of participants with a clinical pregnancy
Time frame: seen as early as 18 days post embryo transfer
number of participants with a live births
Time frame: typically 9 months from embryo transfer
endometrial volume
Time frame: measured at baseline visit during cycle 1 (one month) and after progesterone initiation during cycle 4 (one month)
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Brent Hanson, MD study director
Reproductive Medicine Associates of New Jersey
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMD3100, Normal saline and dilation and curettage in people with Infertility of Uterine Origin, run by Reproductive Medicine Associates of New Jersey at 3 sites in United States.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness (time frame: measured on day prior to progesterone initiation during frozen embryo transfer cycle). 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 19 May 2021; AzTrials last refreshed its copy on 27 Oct 2026.