Endometrial DysfunctionNCT02406690
Endometrial Receptivity Profile in Patients With Endometrial Proliferation Defects
An observational study of Endometrial Dysfunction, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to determine the differences that exist in RNA molecules, the biochemical process of methylation, and estrogen receptor binding in patients that have failed to produce adequate endometrium in synthetic embryo transfer cycles when compared to patients whose endometrium thickness is within… 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
- Endometrial Dysfunction
- What is being tested?
- Estradiol Valerate, Progesterone in Oil, Leuprolide
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2015to 17 Sep 2015
- 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: Patients who have undergone a synthetic endometrial proliferation cycle in preparation for an embryo transfer that were identified as having a proliferative phase defect will serve as the subjects. Normal, healthy patients who are undergoing infertility treatment for single gene disorder, family balancing, or male factor infertility will serve as controls. The study will occur as part of a cryosynthetic preparatory cycle prior to embryo transfer. There will be 10 cases and 10 controls recruited for participation in the study.
Who may be able to join
- Diagnosis of endometrial insufficiency- prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid.
Who cannot join
- Any evidence for surgically induced endometrial insufficiency (Asherman's syndrome)
- Presence of hydrosalpinges that communicate with endometrial cavity
- Any contraindications to undergoing estrogen stimulation of the endometrium
- Age ≥35 years and smoking ≥15 cigarettes per day
- Multiple risk factors for arterial cardiovascular disease (smoking, diabetes, and hypertension)
- Hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
Show all 21Show fewer
- 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 undiagnosed abnormal uterine bleeding.
- Allergic reaction to estradiol valerate, progesterone in oil, leuprolide acetate
- Known pregnancy or delivery within the past 6 months
- Breastfeeding
- Obesity >35 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
The purpose of this study is to determine the differences that exist in RNA molecules, the biochemical process of methylation, and estrogen receptor binding in patients that have failed to produce adequate endometrium in synthetic embryo transfer cycles when compared to patients whose endometrium thickness is within normal limits.
Read the detailed description
The purpose of this study is to determine the differences that may exist in RNA molecules, the biochemical process of methylation, and estrogen receptor binding (this is a group of proteins in the cell that are activated by the hormone estrogen) in patients that have failed to produce adequate endometrium (uterine lining) in synthetic embryo transfer cycles when compared to patients whose endometrium thickness is within normal limits.
Appropriate embryo development and luteal phase (when fertilization and implantation occur) transformation of the endometrium create a small window of opportunity where successful implantation can occur. The interaction between the embryo and the endometrium is complex and poorly understood.
The endometrium, which consists of two layers called the functionalis and basalis, goes through changes during the menstrual cycle. The changes that occur are needed for successful implantation of an embryo. The proliferative phase of the menstrual cycle is primarily governed by estrogen and is responsible for the thickening of the endometrium. Progesterone primarily controls the last half of the menstrual cycle and causes changes which allows for embryo implantation.
Through in vitro fertilization (IVF), the investigators have seen that the correct thickness of endometrium is a marker of successful implantation and ongoing pregnancy, although the reason for this is not entirely clear. In order to better understand the processes that may occur in the endometrium, the investigators are conducting a study which evaluates biochemical markers of those patients who have shown a failure to proliferate during previous synthetic IVF frozen cycles and biochemical markers of control patients who have no known endometrial pathology.
- Conditions
- Endometrial Dysfunction
- Being tested
- Estradiol Valerate, Progesterone in Oil, Leuprolide
- Keywords
- Endometrial Insufficiency, Endometrial Receptivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol Valerate, Progesterone in Oil, LeuprolideOther
Patients will undergo a Leuprolide endometrial preparatory cycle using estradiol valerate, progesterone in oil and once completed will have a uterine aspiration and biopsy performed.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Patients who failed to achieve adequate endometrial lining during a synthetic embryo transfer. This group will undergo a Leuprolide prep cycle using estradiol valerate, progesterone in oil and subsequently undergo an endometrial biopsy and uterine aspiration. Receives: Other: Estradiol Valerate, Progesterone in Oil, Leuprolide | |
| Control Group | Patients who have achieved an adequate endometrial lining. This group will undergo a Leuprolide prep cycle using estradiol valerate, progesterone in oil and subsequently undergo an endometrial biopsy and uterine aspiration. Receives: Other: Estradiol Valerate, Progesterone in Oil, Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the differences that may exist in transcriptome, methylome, and estrogen receptor binding between case and control groups
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study start31 Jul 2015
- Primary completion17 Sep 2015
- Study completion17 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial DysfunctionStudies 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
- 1 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, Jr., MD, HCLD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406690
- Sponsor's protocol ID
- RMA-2014-04
- Status last verified
- Nov 2017
- First submitted
- 30 Mar 2015
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Receptivity Profile in Patients With Endometrial Proliferation Defects
- ClinicalTrials.gov ID
- NCT02406690
- Acronym / sponsor ID
- RMA-2014-04
- Conditions
- Endometrial Dysfunction
- Keywords
- Endometrial Insufficiency, Endometrial Receptivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- 17 Sep 2015 (actual)
- Study completion
- 17 Sep 2015 (actual)
- First posted
- 2 Apr 2015 (estimated)
- 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 determine the differences that exist in RNA molecules, the biochemical process of methylation, and estrogen receptor binding in patients that have failed to produce adequate endometrium in synthetic embryo transfer cycles when compared to patients whose endometrium thickness is within normal limits.
Detailed description
The purpose of this study is to determine the differences that may exist in RNA molecules, the biochemical process of methylation, and estrogen receptor binding (this is a group of proteins in the cell that are activated by the hormone estrogen) in patients that have failed to produce adequate endometrium (uterine lining) in synthetic embryo transfer cycles when compared to patients whose endometrium thickness is within normal limits.
Appropriate embryo development and luteal phase (when fertilization and implantation occur) transformation of the endometrium create a small window of opportunity where successful implantation can occur. The interaction between the embryo and the endometrium is complex and poorly understood.
The endometrium, which consists of two layers called the functionalis and basalis, goes through changes during the menstrual cycle. The changes that occur are needed for successful implantation of an embryo. The proliferative phase of the menstrual cycle is primarily governed by estrogen and is responsible for the thickening of the endometrium. Progesterone primarily controls the last half of the menstrual cycle and causes changes which allows for embryo implantation.
Through in vitro fertilization (IVF), the investigators have seen that the correct thickness of endometrium is a marker of successful implantation and ongoing pregnancy, although the reason for this is not entirely clear. In order to better understand the processes that may occur in the endometrium, the investigators are conducting a study which evaluates biochemical markers of those patients who have shown a failure to proliferate during previous synthetic IVF frozen cycles and biochemical markers of control patients who have no known endometrial pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Other: Estradiol Valerate, Progesterone in Oil, LeuprolidePatients who failed to achieve adequate endometrial lining during a synthetic embryo transfer. This group will undergo a Leuprolide prep cycle using estradiol valerate, progesterone in oil and subsequently undergo an endometrial biopsy and uterine aspiration. |
| Control Group | – | Other: Estradiol Valerate, Progesterone in Oil, LeuprolidePatients who have achieved an adequate endometrial lining. This group will undergo a Leuprolide prep cycle using estradiol valerate, progesterone in oil and subsequently undergo an endometrial biopsy and uterine aspiration. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who have undergone a synthetic endometrial proliferation cycle in preparation for an embryo transfer that were identified as having a proliferative phase defect will serve as the subjects. Normal, healthy patients who are undergoing infertility treatment for single gene disorder, family balancing, or male factor infertility will serve as controls. The study will occur as part of a cryosynthetic preparatory cycle prior to embryo transfer. There will be 10 cases and 10 controls recruited for participation in the study.
Key inclusion criteria (1 listed)
- Diagnosis of endometrial insufficiency- prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid.
Key exclusion criteria (21 listed)
- Any evidence for surgically induced endometrial insufficiency (Asherman's syndrome)
- Presence of hydrosalpinges that communicate with endometrial cavity
- Any contraindications to undergoing estrogen stimulation of the endometrium
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 |
|---|---|---|
| Estradiol Valerate, Progesterone in Oil, LeuprolidePatients will undergo a Leuprolide endometrial preparatory cycle using estradiol valerate, progesterone in oil and once completed will have a uterine aspiration and biopsy performed. | Other | Case Group, Control Group |
Primary outcome
To determine the differences that may exist in transcriptome, methylome, and estrogen receptor binding between case and control groups
Time frame: One year
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 2 Dec 2017.
- 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, Jr., MD, HCLD 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 Endometrial Dysfunction, 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?
The sponsor lists 1 inclusion and 21 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: finished, as of the sponsor's last update on 2 Dec 2017. 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?
To determine the differences that may exist in transcriptome, methylome, and estrogen receptor binding between case and control groups (time frame: One year). 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 2 Dec 2017.