Predictive Value of New AMH Test Method for Ovarian Response

Study Overview
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Brief Summary
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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.

Official Title
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Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI

Conditions
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AMH, Infertility

Intervention / Treatment
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* Diagnostic Test: ELISA
* Diagnostic Test: Chemiluminescence


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ELISA<br>ELISA kit detecting the serum AMH level | Diagnostic Test: ELISA<br>* ELISA kit detecting the serum AMH level<br>* Other names: experimental group;|
| Chemiluminescence<br>CLIA method detecting the serum AMH level | Diagnostic Test: Chemiluminescence<br>* CLIA method detecting the serum AMH level<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the AMH（CLIA） cutoff value of low and high ovarian response | the poor ovarian response :the number of retrieved oocyte ≤ 3,the high ovarian response :the number of retrieved oocyte ≥ 15 | the day of oocytes retrieved，about three months after AMH test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved | the number of oocytes retrieved after hCG trigger | 34-36 hours after hCG trigger，about three months after AMH test | 
| the serum AMH level | anti-muller hormone | any day of the menstrual cycle, about three months after study starting |