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

• Conditions: Infertility

• Registration Number: NCT04203355
• Lead Sponsor: Taipei Medical University

Brief 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.

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 Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-23
• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-mullerian hormone level in general population	within 3 months before controlled ovarian stimulation cycles	Inter-ethnic difference in age-specific AMH level

Secondary Outcome Measures

Name	Time	Method
Anti-mullerian hormone level in PCOS patients	within 3 months before controlled ovarian stimulation cycles	AMH level in PCOS patients vs non-PCOS patients in age-specific intervals
Anti-mullerian hormone level in endometriosis patients	within 3 months before controlled ovarian stimulation cycles	AMH level in endometriosis patients vs non-endometriosis patients in age-specific intervals

Trial Locations

Locations (11)

Women's center by Motherhood Coimbatore; 🇮🇳 Bangalore, Karnataka, India

Victory ART Lab Fertility Center; 🇵🇭 Makati City, Philippines

My Duc Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand

Taipei University Medical Hospital; 🇨🇳 Taipei, Taiwan

Henan Provincial People Hospital; 🇨🇳 Zhengzhou, Henan, China

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Morula IVF center; 🇮🇩 Jakarta, Indonesia

CHA Bundang Medical Center; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Asada Ladies Clinic; 🇯🇵 Nagoya, Aichi, Japan

Tropicana Medical Centre; 🇲🇾 Petaling Jaya, Selangor, Malaysia