Luteal Phase DefectNCT02458404
Effects of Varied Estrogen Doses on Endometrial Receptivity
An observational study of Luteal Phase Defect, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
This study will help determine the effect of varied estradiol levels on the uterine lining in healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle. 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
- Luteal Phase Defect
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2019
- 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: Healthy human subjects
Who may be able to join
- Regular menstrual cycles
- Age 18-50
- Normal Baseline ultrasound
- No intra-uterine procedures in prior 90 days
Who cannot join
- 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)
- Venous thromboembolism (current or history of)
- Known thrombogenic mutations
Show all 19Show fewer
- 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 any study drug
- 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
This study will help determine the effect of varied estradiol levels on the uterine lining in healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle.
Read the detailed description
Volunteers who wish to participate in the study, will undergo a diagnostic and screening phase to determine their eligibility. Once eligibility is determined, participants will undergo three, separate "endometrial preparatory cycles". These cycles will consist of estrogen supplementation to mimic normal, above normal, and highly elevated estradiol levels. Once supplementation is complete uterine procedures will be done to hopefully determine the effects of the estrogen levels on the uterine lining. Subcutaneous leuprolide injections, intramuscular estrogen, and progesterone injections will be used to mimic the levels needed. Blood draws will monitor the needed estradiol and progesterone levels during the injection phase of the cycle. Once the injection phase is complete, transvaginal ultrasound, uterine aspiration, and endometrial biopsy will be done.
- Conditions
- Luteal Phase Defect
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness in millimeters as assessed by transvaginal ultrasound
- Participants will undergo 3 transvaginal ultrasounds. Endometrial thickness will be recorded.
- Purpose: The serum hormone levels serve as the immunoassays while the endometrial lining serves as the bioassay. This will allow for baseline evaluation of the uterine lining and myometrium as well as monitor biological response to the estrogen and progesterone.
Measured: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
mRNA and protein expression of known markers of secretory transformation as assessed by real time PCR and immunohistochemistry after uterine aspiration and disruption/biops
Patients will undergo a uterine aspiration and endometrial disruption/biopsy. These will be analyzed for known markers involved in human reproduction utilizing established molecular biological assessment tools. In particular markers which will be evaluated will be: LIF, CXCL13, beta 2 integrin, DAF, OPN, and IL15
Measured: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
Endometrial echotexture as assessed by transvaginal ultrasound
- Participants will undergo 3 transvaginal ultrasounds. Endometrial echotexture will be recorded.
Measured: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
Secondary outcomes (2)
Peak and trough estrogen and progesterone levels as assessed by peripheral phlebotomy
Peripheral phlebotomy will be performed in order to determine peak and trough levels of hormones.
Measured: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
Uterine microbiome characterization by microbiota presence and prevalence as assessed after uterine aspiration
Patients will undergo a uterine aspiration. The human microbiome project has revealed important things about the vaginal microbiome, but little is known about the uterine microbiome. Given the hormonal changes change the pH of the vagina, we will be able to characterize differences in the uterine microbiome with varied estrogen levels.
Measured: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2017
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Luteal Phase DefectStudies 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
- 19 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, HCLD, Principal investigator, RMA of NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458404
- Sponsor's protocol ID
- RMA-2014-03
- Status last verified
- Nov 2019
- First submitted
- 31 Mar 2015
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Osman EK, Wang T, Zhan Y, Juneau CR, Morin SJ, Seli E, Scott RT, Franasiak JM. Varying levels of serum estradiol do not alter the timing of the early endometrial secretory transformation. Hum Reprod. 2020 Jul 1;35(7):1637-1647. doi: 10.1093/humrep/deaa135.
PubMed 32613240
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Varied Estrogen Doses on Endometrial Receptivity
- ClinicalTrials.gov ID
- NCT02458404
- Acronym / sponsor ID
- RMA-2014-03
- Conditions
- Luteal Phase Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 1 Jun 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.
This study will help determine the effect of varied estradiol levels on the uterine lining in healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle.
Detailed description
Volunteers who wish to participate in the study, will undergo a diagnostic and screening phase to determine their eligibility. Once eligibility is determined, participants will undergo three, separate "endometrial preparatory cycles". These cycles will consist of estrogen supplementation to mimic normal, above normal, and highly elevated estradiol levels. Once supplementation is complete uterine procedures will be done to hopefully determine the effects of the estrogen levels on the uterine lining. Subcutaneous leuprolide injections, intramuscular estrogen, and progesterone injections will be used to mimic the levels needed. Blood draws will monitor the needed estradiol and progesterone levels during the injection phase of the cycle. Once the injection phase is complete, transvaginal ultrasound, uterine aspiration, and endometrial biopsy will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy human subjects
Key inclusion criteria (4 listed)
- Regular menstrual cycles
- Age 18-50
- Normal Baseline ultrasound
- No intra-uterine procedures in prior 90 days
Key exclusion criteria (19 listed)
- 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)
- Venous thromboembolism (current or history of)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endometrial thickness in millimeters as assessed by transvaginal ultrasound
Time frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
1. Participants will undergo 3 transvaginal ultrasounds. Endometrial thickness will be recorded. 2. Purpose: The serum hormone levels serve as the immunoassays while the endometrial lining serves as the bioassay. This will allow for baseline evaluation of the uterine lining and myometrium as well as monitor biological response to the estrogen and progesterone.
mRNA and protein expression of known markers of secretory transformation as assessed by real time PCR and immunohistochemistry after uterine aspiration and disruption/biops
Time frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
Patients will undergo a uterine aspiration and endometrial disruption/biopsy. These will be analyzed for known markers involved in human reproduction utilizing established molecular biological assessment tools. In particular markers which will be evaluated will be: LIF, CXCL13, beta 2 integrin, DAF, OPN, and IL15
Endometrial echotexture as assessed by transvaginal ultrasound
Time frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
a. Participants will undergo 3 transvaginal ultrasounds. Endometrial echotexture will be recorded.
2 secondary outcomes
Peak and trough estrogen and progesterone levels as assessed by peripheral phlebotomy
Time frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
Uterine microbiome characterization by microbiota presence and prevalence as assessed after uterine aspiration
Time frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days
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 7 Nov 2019.
- Derived from this study: PubMed 32613240Osman EK, Wang T, Zhan Y, Juneau CR, Morin SJ, Seli E, Scott RT, Franasiak JM. Varying levels of serum estradiol do not alter the timing of the early endometrial secretory transformation. Hum Reprod. 2020 Jul 1;35(7):1637-1647. doi: 10.1093/humrep/deaa135.
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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, HCLD principal investigator
RMA of NJ
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 Luteal Phase Defect, 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 4 inclusion and 19 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 7 Nov 2019. 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?
Endometrial thickness in millimeters as assessed by transvaginal ultrasound (time frame: Participants will be followed for the duration of 1 menstrual cycle, ~30 days; this is followed by 1 rest mentrual cycle, ~30 days; there are a total of 3 rest and 3 treatment cycles, ~180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458404, which also lists 1 linked publication.
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 7 Nov 2019.