Predictive Value of New AMH Test Method for Ovarian Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

454 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-15

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In China, the incidence of infertility is about 15%, and patients need to use assisted reproductive technology (ART) to obtain pregnancy. It is particularly important to accurately predict the patient's ovarian response before initiating controlled ovulation hyperstimulation (COH). At present, the commonly used AMH detection method is enzyme-linked immunoassay (ELISA), and it has obtained the normal reference range for ovarian response. In recent years, with the development of detection technology, chemiluminescence immunoassay（CLIA） detection reagents have been successively used for the detection of AMH. However, there are few studies on the comparison of these two detection methods. The predictive value of the new method on ovarian response was lack. Therefore, by comparing the two methods of ELISA and CLIA detection of AMH levels in this study, the predictive value of poor ovarian response (the number of retrieved oocyte ≤ 3) and high response (the number of retrieved oocyte ≥ 15) in IVF/ICSI stimulation cycle was analyzed. In order to provide more reference basis for individualized COH, the AMH cutoff value of low and high ovarian response by the new method predicts was analyzed. At the same time, the prediction value of the two methods is compared to determine whether the new CLIA is suitable for clinical application.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anti-Müllerian Hormone (AMH) Measured With Fully Automated Assay Versus AFC in the Prediction of Ovarian Response

NCT04168892

Ovarian Response

COMPLETED

Anti-Müllerian Hormone is Not Predictive of Pregnancy in Donor Insemination Cycles in Non-infertile Women

NCT03160872

Infertility

COMPLETED

Antimullerian Hormone as an Indicator for Ovarian Response

NCT03291860

Infertility, Female

UNKNOWN

Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins

NCT02237781

Female Infertility

UNKNOWN PHASE2/PHASE3

AMH and Pregnancy Outcome in IVF

NCT04512807

AMH

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility AMH

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ELISA

ELISA kit detecting the serum AMH level

ELISA

Intervention Type DIAGNOSTIC_TEST

ELISA kit detecting the serum AMH level

Chemiluminescence

CLIA method detecting the serum AMH level

Chemiluminescence

Intervention Type DIAGNOSTIC_TEST

CLIA method detecting the serum AMH level

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ELISA

ELISA kit detecting the serum AMH level

Intervention Type DIAGNOSTIC_TEST

Chemiluminescence

CLIA method detecting the serum AMH level

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

experimental group control group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The first IVF/ICSI COH cycle;
* the causes of infertility :fallopian tube factors and/or male factors;

Exclusion Criteria

* Endometriosis;
* PCOS;
* Adenomyosis;
* PGT cycle because of the female chromosome abnormality or genetic abnormality;
* FET cycle;
* Malignant tumor patient.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No