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Predictive Value of New AMH Test Method for Ovarian Response

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04639505
Enrollment
454
Registered
2020-11-20
Start date
2020-11-15
Completion date
2021-09-30
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AMH, Infertility

Brief summary

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.

Interventions

DIAGNOSTIC_TESTELISA

ELISA kit detecting the serum AMH level

DIAGNOSTIC_TESTChemiluminescence

CLIA method detecting the serum AMH level

Sponsors

Reproductive & Genetic Hospital of CITIC-Xiangya
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
the AMH(CLIA) cutoff value of low and high ovarian responsethe day of oocytes retrieved,about three months after AMH testthe poor ovarian response :the number of retrieved oocyte ≤ 3,the high ovarian response :the number of retrieved oocyte ≥ 15

Secondary

MeasureTime frameDescription
Number of oocytes retrieved34-36 hours after hCG trigger,about three months after AMH testthe number of oocytes retrieved after hCG trigger
the serum AMH levelany day of the menstrual cycle, about three months after study startinganti-muller hormone

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026