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

December 19, 2019 updated by: Taipei Medical University
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Henan Provincial People Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560001
        • Women's center by Motherhood Coimbatore
  • Indonesia
      • Jakarta, Indonesia
        • Morula IVF center
  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 450-0002
        • Asada Ladies Clinic
  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of
        • CHA Bundang Medical Center
  • Malaysia
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 47810
        • Tropicana Medical Centre
  • Philippines
      • Makati City, Philippines
        • Victory ART Lab Fertility Center
  • Taiwan
      • Taipei, Taiwan
        • Taipei University Medical Hospital
  • Thailand
      • Chiang Mai, Thailand
        • Chiang Mai University
  • Vietnam
      • Ho Chi Minh City, Vietnam
        • My Duc Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 3 months before controlled ovarian stimulation cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-mullerian hormone level in PCOS patients
Time Frame: within 3 months before controlled ovarian stimulation cycles
AMH level in PCOS patients vs non-PCOS patients in age-specific intervals
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
AMH level in endometriosis patients vs non-endometriosis patients in age-specific intervals
within 3 months before controlled ovarian stimulation cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Investigators

  • Principal Investigator: Chii-Ruey Tzeng, MD, Ph.D, Taipei Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU201912130

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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