Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients

Infertility Clinical Trial

Official title:

Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04203355
• Other study ID #: TMU201912130
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: December 2019
• Source: Taipei Medical University
• Contact: Chii-Ruey Tzeng, MD, Ph.D
• Phone: +88 622 737 2181
• Email: tzengcr[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: May 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

Inclusion Criteria:

• Diagnosed as infertile couple

• Naive patients who plan to enter their first ovarian stimulation cycles

• Women among 20-43 years old

Exclusion Criteria:

• Systematic disease that impact AMH (eg. systemic lupus erythematosus (SLE), Crohn's disease etc.)

• Chemotherapy history

• Alcohol abuse

• Currently taking oral contraceptive pills

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
China	Henan Provincial People Hospital	Zhengzhou	Henan
Hong Kong	Queen Mary Hospital	Hong Kong
India	Women's center by Motherhood Coimbatore	Bangalore	Karnataka
Indonesia	Morula IVF center	Jakarta
Japan	Asada Ladies Clinic	Nagoya	Aichi
Korea, Republic of	CHA Bundang Medical Center	Seongnam	Gyeonggi-do
Malaysia	Tropicana Medical Centre	Petaling Jaya	Selangor
Philippines	Victory ART Lab Fertility Center	Makati City
Taiwan	Taipei University Medical Hospital	Taipei
Thailand	Chiang Mai University	Chiang Mai
Vietnam	My Duc Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Countries where clinical trial is conducted

China,  Hong Kong,  India,  Indonesia,  Japan,  Korea, Republic of,  Malaysia,  Philippines,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-mullerian hormone level in general population	Inter-ethnic difference in age-specific AMH level	within 3 months before controlled ovarian stimulation cycles
Secondary	Anti-mullerian hormone level in PCOS patients	AMH level in PCOS patients vs non-PCOS patients in age-specific intervals	within 3 months before controlled ovarian stimulation cycles
Secondary	Anti-mullerian hormone level in endometriosis patients	AMH level in endometriosis patients vs non-endometriosis patients in age-specific intervals	within 3 months before controlled ovarian stimulation cycles