Infertility, FemaleNCT04141085
Transcriptomic Evaluation of Endometrial Receptivity
An observational study of Infertility, Female, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to comprehensively evaluate the transcriptomic signal of the endometrium before, during, and after the window of receptivity. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Endometrial biopsy
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 15 Dec 2022
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Phase 1: Healthy volunteers without a history of infertility will be recruited for the first phase to undergo an endometrial biopsy on a randomized cycle day surrounding the window of implantation Phase 2: Healthy volunteers with a history of infertility but without concern for endometrial dysfunction will be recruited for the second phase to undergo an endometrial biopsy during a preparatory IVF cycle.
Phase 1:
Major Inclusion: The following are major inclusion criteria:
- Regular menstrual cycles
- Age 18-50
- Normal baseline ultrasound
- No intrauterine procedures in prior 90 days
Exclusions: The following are exclusion criteria:
- Any contraindications to undergoing estrogen stimulation of the endometrium
- Current smoking status
- Multiple risk factors for arterial cardiovascular disease (smoking, diabetes, and hypertension)
- Hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Venous thromboembolism (current or history of)
- Known thrombogenic mutations
- Known ischemic heart disease
- History of stroke
- Complicated valvular heart disease (pulmonary hypertension, risk for atrial fibrillation, history of subacute bacterial endocarditis)
- Systemic lupus erythematosus (positive or unknown antiphospholipid antibodies)
- Migraine with aura at any age
- Breast cancer
- Cirrhosis
- Hepatocellular adenoma or malignant hepatoma
- History of infertility diagnosis
- History of undiagnosed abnormal uterine bleeding.
- Allergic reaction to any medication used for the preparatory cycle
- Known pregnancy or delivery within the past 6 months
- Breastfeeding
- Obesity >35 kg/m2
Phase 2
Major Inclusion: The following are major inclusion criteria:
- Age 18-50
- Diagnosis of infertility with low endometrial risk
- No intrauterine procedures in prior 90 days
Exclusions: In addition to the exclusion criteria for phase 1, patients deemed to have an elevated endometrial risk will also be excluded. This would include the following:
- Recurrent implantation failure
- Failed transfer with a euploid blastocyst
- History of Asherman's or abnormal endometrial function
- History of endometriosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Assoicates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
The purpose of this study is to comprehensively evaluate the transcriptomic signal of the endometrium before, during, and after the window of receptivity.
Read the detailed description
Phase 1 will aim to define a normal endometrial transcriptomic signature in healthy controls without infertility. Phase 2 will elucidate endometrial transcriptomic expression in patients with diagnoses of infertility unrelated to endometrial factor. Findings from this phase will be compared to the results of phase 1.
- Conditions
- Infertility, Female
- Being tested
- Endometrial biopsy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsyOther
All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers without infertility | Healthy volunteers without a history of infertility who have regular menstrual cycles and whom have not had any intrauterine procedures performed in the last 90 days prior to participation in the study Receives: Other: Endometrial biopsy | |
| Infertile Patients | Infertile patients with a history of infertility but without concern for endometrial dysfunction as the cause of their infertility. Receives: Other: Endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
transcriptomic evaluation
evaluation to characterize genes expressed during the window of implantation
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start28 Jan 2020
- Primary completion31 Jan 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141085
- Sponsor's protocol ID
- RMA-2019-01
- Status last verified
- May 2023
- First submitted
- 24 Oct 2019
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomic Evaluation of Endometrial Receptivity
- ClinicalTrials.gov ID
- NCT04141085
- Acronym / sponsor ID
- RMA-2019-01
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 28 Oct 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.
The purpose of this study is to comprehensively evaluate the transcriptomic signal of the endometrium before, during, and after the window of receptivity.
Detailed description
Phase 1 will aim to define a normal endometrial transcriptomic signature in healthy controls without infertility. Phase 2 will elucidate endometrial transcriptomic expression in patients with diagnoses of infertility unrelated to endometrial factor. Findings from this phase will be compared to the results of phase 1.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers without infertility | – | Other: Endometrial biopsyHealthy volunteers without a history of infertility who have regular menstrual cycles and whom have not had any intrauterine procedures performed in the last 90 days prior to participation in the study |
| Infertile Patients | – | Other: Endometrial biopsyInfertile patients with a history of infertility but without concern for endometrial dysfunction as the cause of their infertility. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Phase 1: Healthy volunteers without a history of infertility will be recruited for the first phase to undergo an endometrial biopsy on a randomized cycle day surrounding the window of implantation Phase 2: Healthy volunteers with a history of infertility but without concern for endometrial dysfunction will be recruited for the second phase to undergo an endometrial biopsy during a preparatory IVF cycle.
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 biopsyAll groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer | Other | Healthy volunteers without infertility, Infertile Patients |
Primary outcome
transcriptomic evaluation
Time frame: 90 days
evaluation to characterize genes expressed during the window of implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- 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.
Richard T Scott, MD principal investigator
Reproductive Medicine Associates of New Jersey
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 Infertility, Female, run by Reproductive Medicine Associates of New Jersey at 1 site 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?
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: finished, as of the sponsor's last update on 3 May 2023. 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 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
transcriptomic evaluation (time frame: 90 days). 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 May 2023.