AmenorrheaOMGNCT04424576
Ovarian Morphology in Girls
An observational study of Amenorrhea and Oligomenorrhea, run by Cornell University at 3 sites in United States.
Trial summary
Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and… Read more about this study
- Who is it for?
- Ages 9 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amenorrhea, Oligomenorrhea, Puberty
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jan 2020to 31 Mar 2025
- 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 9 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Female adolescents between the ages of 9 and 17 years who achieved menarche (i.e., very first period) within the past 11 months will be recruited.
Who may be able to join
- Female adolescents aged 9 to 17 years
- Menarche within 11 months of the enrollment visit
- University of Rochester site only: Family history of PCOS (i.e., mother or aunt)
Who cannot join
- Current or recent use of medications or supplements known or suspected to interfere with reproductive or metabolic function in the past 2 months (e.g., contraceptives, metformin, steroids, anti-seizure medications)
- Untreated and/or unstable medical or mental health condition known or suspected to interfere with reproductive or metabolic function
- Currently pregnant or breast feeding
- History of ovarian surgery
- Presence of significant acute or chronic illness which may interfere with study participation
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 1 recruiting
- Completed
Cornell University - Human Metabolic Research Unit
Ithaca, New York, 14853
- Completed
Children's Mercy Hospital
Kansas City, Missouri, 64108
- Recruiting
University of Rochester, Strong Fertility Center
Rochester, New York, 14623
Kathleen Hoeger, MD, kathy_hoeger@urmc.rochester.edu
About this study
Official title: Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition
Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive disturbances such as polycystic ovary syndrome (PCOS). The purpose of this research study is to determine whether the ovary can serve as a reliable predictor of normal or abnormal development by following the trajectory of ovarian morphology in conjunction with menstrual cyclicity using 3D transabdominal ultrasound imaging in a prospective cohort study of adolescents. A secondary objective is to identify potential environmental factors such as diet and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development.
Read the detailed description
Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive perturbations and subsequent future disease risk. Therefore, the objectives of this study are to determine whether there are distinct aspects of ovarian morphology that predict the likelihood of regular menses or cycle irregularity at 2y post-menarche and to determine whether diet or lifestyle (such as quality of sleep) contribute to changes in the ovaries and period patterns.
A group of up to 60 adolescents will be enrolled into a prospective longitudinal cohort study. Participants will attend four study visits to their location's respective clinical research center. Study visits will occur at four distinct time points post-menarche: 6-10 months, 11-13 months, 17-19 months, and 23-25 months.
Prior to each of the study visits, participants will undergo one planned 24-hr dietary recall by a member of the research team and self-collect a stool sample.* Participants will be asked to fast the night before the study visit. At each study visit, participants will undergo the following assessments:
A 3D transabdominal ultrasound of the ovaries and uterus.
A fasting blood sample, obtained via venipuncture.
A series of anthropometric assessments, including: height, weight, waist and hip circumference, blood pressure, heart rate, and body fat percentage obtained using a bioimpedance scale.
Tanner stage assessment, using a standardized self-report scoring scheme and by a trained member of the research team who is blinded to the results of the self-reported tanner stage.
Acne scoring, using a standardized scoring scheme by a member of the research team.
Hirsutism assessment, obtained by visually inspecting nine pre-defined regions of the body for terminal hair growth using a standardized scoring scheme by a trained member of the research team.
Urine sample, self-collected by the participant after the transabdominal ultrasound.*
24-hour dietary recall.*
Physical activity questionnaire.*
Two sleep questionnaires, including questions about sleep hygiene, sleep quality, and circadian rhythms.*
In between study visits, participants will maintain menstrual cycle diaries and medication diaries.
*Participants at the University of Rochester site will not complete the urine or stool collection, the dietary recalls, or any of the physical activity and sleep questionnaires.
- Conditions
- Amenorrhea, Oligomenorrhea, Puberty
- Keywords
- Ovary, Transabdominal Ultrasound, Menarche, Periods, Microbiome
- Medical subject headings
- Amenorrhea, Oligomenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Regular Menstrual Cycles | 22 adolescents with regular menstrual cycles (i.e., once every 4-6 weeks) will be enrolled within 11 months of menarche. | |
| Irregular Menstrual Cycles | 26 adolescents with irregular menstrual cycles (i.e., < 4 weeks or > 6 weeks between periods) will be enrolled within 11 months of menarche. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian size
Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.
Measured: 24 months
Follicle counts
Follicle counts, expressed as follicle number per ovary (FNPO) and follicle number per cross-section (FNPS), will be assessed over the first 2y post-menarche and compared across cohorts. Numbers of large follicles (>10 mm diameter) and small follicles (<10 mm diameter) will also be compared across cohorts.
Measured: 24 months
Menstrual cycle status
Menstrual cycle status (i.e., regular versus irregular menstrual cycles) will be assessed using menstrual cycle records maintained by participants over the course of the study. Changes in menstrual cycle status over the 2y post-menarche and relationships between menstrual cycle status and other physiological and lifestyle factors will be examined.
Measured: 24 months
Secondary outcomes (5)
Body composition
Changes in percent body fat, obtained using a bioimpedence scale, will be assessed over the first 2y post-menarche and compared across cohorts.
Measured: 24 months
Leutenizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone, anti-mullerian hormone, free and total testosterone, and androstenedione
Serum levels of these reproductive hormones will be assessed over the first 2y post-menarche and compared across cohorts.
Measured: 24 months
Sleep quality
Sleep quality will be assessed using two questionnaires: the Morningness-Eveningness Scale for Children and the Children's Report of Sleep Patterns. Sleep quality will be assessed over the first 2y post-menarche and compared across cohorts.
Measured: 24 months
Dietary composition
Dietary composition (i.e., macro and micronutrient totals, total energy intake) will be assessed using two 24-Hour Food Frequency Questionnaires administered at each gynecological time point.
Measured: 24 months
Gut microbiome richness and diversity
Gut microbiome richness and diversity will be assessed over the first 2y post-menarche and compared across cohorts.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start31 Jan 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City
- Responsible party
- Sponsor
- Investigators
- Marla E Lujan, PhD, Principal investigator, Cornell UniversityTania Burgert, MD, Principal investigator, Children's Mercy Hospital Kansas CityRomina Barral, MD MSCR FAPP, Principal investigator, Children's Mercy Hospital Kansas CityKathleen Hoeger, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424576
- Sponsor's protocol ID
- IRB# 0000779
- Acronym
- OMG
- Status last verified
- Aug 2024
- First submitted
- 18 May 2020
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition
- ClinicalTrials.gov ID
- NCT04424576
- Acronym / sponsor ID
- OMG / IRB# 0000779
- Conditions
- Amenorrhea, Oligomenorrhea, Puberty
- Keywords
- Ovary, Transabdominal Ultrasound, Menarche, Periods, Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Jun 2020 (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.
Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive disturbances such as polycystic ovary syndrome (PCOS). The purpose of this research study is to determine whether the ovary can serve as a reliable predictor of normal or abnormal development by following the trajectory of ovarian morphology in conjunction with menstrual cyclicity using 3D transabdominal ultrasound imaging in a prospective cohort study of adolescents. A secondary objective is to identify potential environmental factors such as diet and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development.
Detailed description
Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive perturbations and subsequent future disease risk. Therefore, the objectives of this study are to determine whether there are distinct aspects of ovarian morphology that predict the likelihood of regular menses or cycle irregularity at 2y post-menarche and to determine whether diet or lifestyle (such as quality of sleep) contribute to changes in the ovaries and period patterns.
A group of up to 60 adolescents will be enrolled into a prospective longitudinal cohort study. Participants will attend four study visits to their location's respective clinical research center. Study visits will occur at four distinct time points post-menarche: 6-10 months, 11-13 months, 17-19 months, and 23-25 months.
Prior to each of the study visits, participants will undergo one planned 24-hr dietary recall by a member of the research team and self-collect a stool sample.* Participants will be asked to fast the night before the study visit. At each study visit, participants will undergo the following assessments:
A 3D transabdominal ultrasound of the ovaries and uterus.
A fasting blood sample, obtained via venipuncture.
A series of anthropometric assessments, including: height, weight, waist and hip circumference, blood pressure, heart rate, and body fat percentage obtained using a bioimpedance scale.
Tanner stage assessment, using a standardized self-report scoring scheme and by a trained member of the research team who is blinded to the results of the self-reported tanner stage.
Acne scoring, using a standardized scoring scheme by a member of the research team.
Hirsutism assessment, obtained by visually inspecting nine pre-defined regions of the body for terminal hair growth using a standardized scoring scheme by a trained member of the research team.
Urine sample, self-collected by the participant after the transabdominal ultrasound.*
24-hour dietary recall.*
Physical activity questionnaire.*
Two sleep questionnaires, including questions about sleep hygiene, sleep quality, and circadian rhythms.*
In between study visits, participants will maintain menstrual cycle diaries and medication diaries.
*Participants at the University of Rochester site will not complete the urine or stool collection, the dietary recalls, or any of the physical activity and sleep questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Menstrual Cycles | – | –22 adolescents with regular menstrual cycles (i.e., once every 4-6 weeks) will be enrolled within 11 months of menarche. |
| Irregular Menstrual Cycles | – | –26 adolescents with irregular menstrual cycles (i.e., < 4 weeks or > 6 weeks between periods) will be enrolled within 11 months of menarche. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Female adolescents between the ages of 9 and 17 years who achieved menarche (i.e., very first period) within the past 11 months will be recruited.
Key inclusion criteria (3 listed)
- Female adolescents aged 9 to 17 years
- Menarche within 11 months of the enrollment visit
- University of Rochester site only: Family history of PCOS (i.e., mother or aunt)
Key exclusion criteria (5 listed)
- Current or recent use of medications or supplements known or suspected to interfere with reproductive or metabolic function in the past 2 months (e.g., contraceptives, metformin, steroids, anti-seizure medications)
- Untreated and/or unstable medical or mental health condition known or suspected to interfere with reproductive or metabolic function
- Currently pregnant or breast feeding
- History of ovarian surgery
- Presence of significant acute or chronic illness which may interfere with study participation
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
Ovarian size
Time frame: 24 months
Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.
Follicle counts
Time frame: 24 months
Follicle counts, expressed as follicle number per ovary (FNPO) and follicle number per cross-section (FNPS), will be assessed over the first 2y post-menarche and compared across cohorts. Numbers of large follicles (>10 mm diameter) and small follicles (<10 mm diameter) will also be compared across cohorts.
Menstrual cycle status
Time frame: 24 months
Menstrual cycle status (i.e., regular versus irregular menstrual cycles) will be assessed using menstrual cycle records maintained by participants over the course of the study. Changes in menstrual cycle status over the 2y post-menarche and relationships between menstrual cycle status and other physiological and lifestyle factors will be examined.
5 secondary outcomes
Body composition
Time frame: 24 months
Leutenizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone, anti-mullerian hormone, free and total testosterone, and androstenedione
Time frame: 24 months
Sleep quality
Time frame: 24 months
Dietary composition
Time frame: 24 months
Gut microbiome richness and diversity
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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.
Marla E Lujan, PhD principal investigator
Cornell University
Tania Burgert, MD principal investigator
Children's Mercy Hospital Kansas City
Romina Barral, MD MSCR FAPP principal investigator
Children's Mercy Hospital Kansas City
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amenorrhea and Oligomenorrhea, run by Cornell University 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bailey Smith, MS (218-308-0560, bmd82@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian size (time frame: 24 months). 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?
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 12 Aug 2024.