Clinical trial NCT04203355: Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients
Official title: Multi-country, Multi-center Cohort Study of Anti-Mullerian Hormone Profile in Asia Pacific Infertile Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Anti-mullerian hormone level in general population
timeFrame: within 3 months before controlled ovarian stimulation cycles
Secondary outcomes:
measure: Anti-mullerian hormone level in PCOS patients
timeFrame: within 3 months before controlled ovarian stimulation cycles
measure: Anti-mullerian hormone level in endometriosis patients
timeFrame: within 3 months before controlled ovarian stimulation cycles
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People Hospital
state: Henan
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Bangalore
country: India
facility: Women's center by Motherhood Coimbatore
state: Karnataka
city: Jakarta
country: Indonesia
facility: Morula IVF center
city: Nagoya
country: Japan
facility: Asada Ladies Clinic
state: Aichi
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Petaling Jaya
country: Malaysia
facility: Tropicana Medical Centre
state: Selangor
city: Makati City
country: Philippines
facility: Victory ART Lab Fertility Center
city: Taipei
country: Taiwan
facility: Taipei University Medical Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Chii-Ruey Tzeng, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: