InfertilityNCT04203355
Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients
An observational study of Infertility, run by Taipei Medical University at 11 sites in 11 countries.
Trial summary
This study is to detect the infertile couple (women) Anti-Mullerian Hormone (AMH) profile in major subgroups such as Poly Cystic Ovarian Syndrome (PCOS), Endometriosis, etc via age intervals and ethnic difference. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 4,000 participants
- Where
- 11 sitesin 11 countries
- Study dates
- 1 Jan 2020to 31 May 2021
- 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 20 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Those diagnosed as infertile couples (male or female infertility) and plan to enter their first ovarian stimulation cycles. Those women are 20-43 years old are enrolled in this study.
Who may be able to join
- Diagnosed as infertile couple
- Naive patients who plan to enter their first ovarian stimulation cycles
- Women among 20-43 years old
Who cannot join
- Systematic disease that impact AMH (eg. systemic lupus erythematosus (SLE), Crohn's disease etc.)
- Chemotherapy history
- Alcohol abuse
- Currently taking oral contraceptive pills
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
China1 site
Henan Provincial People Hospital
Zhengzhou, Henan
Cuilian Zhang, MD, PhD, luckyzcl@qq.com
Hong Kong1 site
Queen Mary Hospital
Hong Kong
Raymond HW Li, MD, PhD, raymondli@hku.hk
India1 site
Women's center by Motherhood Coimbatore
Bangalore, Karnataka, 560001
Mirudhubashini Govindarajan, MD, Ph D, mgr@our-mail.com
Japan1 site
Asada Ladies Clinic
Nagoya, Aichi-ken, 450-0002
Yoshimasa Asada, MD, Ph D, y_asada@ivf-asada.jp
Malaysia1 site
Tropicana Medical Centre
Petaling Jaya, Selangor, 47810
Surinder Singh, MD, ecols68@yahoo.com.sg
Philippines1 site
Victory ART Lab Fertility Center
Makati City
Gregorio B Pastorfide, MD, gbp71642@info.com.ph
South Korea1 site
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
Ji Hyang Kim, MD. Ph. D, bin0902@chamc.co.kr
Taiwan1 site
Taipei University Medical Hospital
Taipei
Chii-Ruey Tzeng, MD, Ph. D, +88 6227372181 ext. 8545, tzengcr@tmu.edu.tw
Thailand1 site
Chiang Mai University
Chiang Mai
Teraporn Vutyavanich, MD, Ph D, tvutyava@gmail.com
Vietnam1 site
My Duc Hospital
Ho Chi Minh City
Ho Manh Tuong, MD, Ph D, homanhtuong@yahoo.com
About this study
This study is to detect the infertile couple (women) Anti-Mullerian Hormone (AMH) profile in major subgroups such as Poly Cystic Ovarian Syndrome (PCOS), Endometriosis, etc via age intervals and ethnic difference.
Read the detailed description
To consecutively enroll infertile couple (women) who are undergoing their first controlled ovarian stimulation cycles.
To mainly compare the inter-ethnic difference in age-specific AMH profile in unexplained infertility, male factor infertility, PCOS, Endometriosis etc. subgroups.
To detect the influence of past or present smoking on age-specific AMH levels To study the influence of body mass index (BMI) on age specific AMH levels
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-mullerian hormone level in general population
Inter-ethnic difference in age-specific AMH level
Measured: within 3 months before controlled ovarian stimulation cycles
Secondary outcomes (2)
Anti-mullerian hormone level in PCOS patients
AMH level in PCOS patients vs non-PCOS patients in age-specific intervals
Measured: within 3 months before controlled ovarian stimulation cycles
Anti-mullerian hormone level in endometriosis patients
AMH level in endometriosis patients vs non-endometriosis patients in age-specific intervals
Measured: within 3 months before controlled ovarian stimulation cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 May 2021 (estimated)
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 InfertilityStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chii-Ruey Tzeng, MD, Ph.D, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203355
- Sponsor's protocol ID
- TMU201912130
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tzeng CR, Huang Z, Asada Y, Zhang C, Ho MT, Li RHW, Kim JH, Govindarajan M, Vuyavanich T, Sini I, Wong PS, Singh S, Lin WY, Ho NT. Factors affecting the distribution of serum anti-mullerian hormone levels among infertile Asian women: a multi-nation, multi-centre, and multi-ethnicity prospective cohort study. Hum Reprod. 2023 Jul 5;38(7):1368-1378. doi: 10.1093/humrep/dead081.
PubMed 37105234
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients
- ClinicalTrials.gov ID
- NCT04203355
- Acronym / sponsor ID
- TMU201912130
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 18 Dec 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.
This study is to detect the infertile couple (women) Anti-Mullerian Hormone (AMH) profile in major subgroups such as Poly Cystic Ovarian Syndrome (PCOS), Endometriosis, etc via age intervals and ethnic difference.
Detailed description
To consecutively enroll infertile couple (women) who are undergoing their first controlled ovarian stimulation cycles.
To mainly compare the inter-ethnic difference in age-specific AMH profile in unexplained infertility, male factor infertility, PCOS, Endometriosis etc. subgroups.
To detect the influence of past or present smoking on age-specific AMH levels To study the influence of body mass index (BMI) on age specific AMH levels
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Those diagnosed as infertile couples (male or female infertility) and plan to enter their first ovarian stimulation cycles. Those women are 20-43 years old are enrolled in this study.
Key inclusion criteria (3 listed)
- Diagnosed as infertile couple
- Naive patients who plan to enter their first ovarian stimulation cycles
- Women among 20-43 years old
Key exclusion criteria (4 listed)
- Systematic disease that impact AMH (eg. systemic lupus erythematosus (SLE), Crohn's disease etc.)
- Chemotherapy history
- Alcohol abuse
- Currently taking oral contraceptive pills
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
Anti-mullerian hormone level in general population
Time frame: within 3 months before controlled ovarian stimulation cycles
Inter-ethnic difference in age-specific AMH level
2 secondary outcomes
Anti-mullerian hormone level in PCOS patients
Time frame: within 3 months before controlled ovarian stimulation cycles
Anti-mullerian hormone level in endometriosis patients
Time frame: within 3 months before controlled ovarian stimulation cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Derived from this study: PubMed 37105234Tzeng CR, Huang Z, Asada Y, Zhang C, Ho MT, Li RHW, Kim JH, Govindarajan M, Vuyavanich T, Sini I, Wong PS, Singh S, Lin WY, Ho NT. Factors affecting the distribution of serum anti-mullerian hormone levels among infertile Asian women: a multi-nation, multi-centre, and multi-ethnicity prospective cohort study. Hum Reprod. 2023 Jul 5;38(7):1368-1378. doi: 10.1093/humrep/dead081.
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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.
Chii-Ruey Tzeng, MD, Ph.D principal investigator
Taipei Medical University Hospital
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Taipei Medical University at 11 sites in 11 countries.
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 4 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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, Hong Kong, India, Indonesia, Japan and 6 more countries. 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 Chii-Ruey Tzeng, MD, Ph.D (+88 622 737 2181 ext. 8545, tzengcr@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-mullerian hormone level in general population (time frame: within 3 months before controlled ovarian stimulation cycles). 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 NCT04203355, 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 23 Dec 2019.