NCT05858307

Brief Summary

This study aims to assess the association of Anti-Müllerian hormone (AMH) with polycystic ovarian syndrome, premature ovarian insufficiency and fertility. The main objectives include the following:

  1. 1.To study the level of serum AMH in women with PCOS and to evaluate the utility of serum AMH in the diagnosis of PCOS.
  2. 2.To evaluate the level of serum AMH in women with POI and to evaluate the utility of serum AMH in the management of POI.
  3. 3.To evaluate the associations of basal AMH level with FSH level and AFC respectively for women undergoing ART treatment.
  4. 4.To determine the optimal regimen of gonadotropin for ovarian stimulation for women undergoing ART treatment.
  5. 5.To evaluate the predictive value of serum AMH in reproductive outcomes including oocyte quality, embryo quality, pregnancy loss, clinical pregnancy and live birth rate in women undergoing ART treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jun 2022Dec 2026

Study Start

First participant enrolled

June 22, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

February 6, 2023

Last Update Submit

March 26, 2025

Conditions

Anti-Müllerian HormonePolycystic Ovarian SyndromePremature Ovarian InsufficiencyFertility Issues

Keywords

Anti-Müllerian hormonePolycystic Ovarian SyndromePremature Ovarian InsufficiencyAssisted Reproductive Technology treatmentPredictive valueReproductive outcomesAMHPCOSPOI

Outcome Measures

Primary Outcomes (1)

  • Serum anti-Müllerian hormone (AMH) (pmol/L)

    To evaluate the serum AMH level of women who undergo investigation for polycystic ovarian syndrome (PCOS), premature ovarian insufficiency (POI) or subfertility

    Within 1 to 2 months after the day of recruitment

Secondary Outcomes (9)

  • Type of gonadotropin used for ovarian stimulation

    From the first 1 day to last 1 day of ovarian stimulation during ART treatment

  • Total gonadotropin dose used for ovarian stimulation

    On the last 1 day of ovarian stimulation during ART treatment

  • Number of oocytes retrieved

    On the 1 day of oocyte retrieval during ART treatment

  • Serum follicle stimulation hormone (FSH) (IU/L)

    On the first 1 day of ovarian stimulation during ART treatment

  • Serum luteinising hormone (LH) (IU/L)

    On the first 1 day of ovarian stimulation during ART treatment

  • +4 more secondary outcomes

Eligibility Criteria

Age10 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The following clients will be included in our study population. * Women attending the Paediatric and Adolescent Gynaecological Clinic and Gynaecological Endocrine Clinic of in the Department of Obstetrics and Gynaecology at the Prince of Wales Hospital for the management of PCOS and POI * Women attending the Assisted Reproductive Technology (ART) Unit of The Chinese University of Hong Kong for ART treatment

You may qualify if:

  • Women attending the Paediatric and Adolescent Gynaecological Clinic and Gynaecological Endocrine Clinic of in the Department of Obstetrics and Gynaecology at the Prince of Wales Hospital for the management of PCOS and POI
  • Women attending the Assisted Reproductive Technology (ART) Unit of The Chinese University of Hong Kong for ART treatment

You may not qualify if:

  • Women with age \<10 or ≥45
  • Current or past diseases affecting gonadotropin, sex steroid secretion, clearance and excretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Polycystic Ovary SyndromePrimary Ovarian InsufficiencyInfertility

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • PUI WAH JACQUELINE CHUNG

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

WING IU LI

CONTACT

+852 35051764wingiuli@cuhk.edu.hk

PUI WAH JACQUELINE CHUNG

CONTACT

+852 35051537jacquelinechung@cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 6, 2023

First Posted

May 15, 2023

Study Start

June 22, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

HK(1)