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Predictive Value of New AMH Test Method for Ovarian Response

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ClinicalTrials.gov Identifier: NCT04639505
Recruitment Status : Completed
First Posted : November 20, 2020
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

Study Description
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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.

Condition or disease Intervention/treatment
Infertility AMH Diagnostic Test: ELISA Diagnostic Test: Chemiluminescence

Study Design
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Study Type : Observational
Actual Enrollment : 454 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI
Actual Study Start Date : November 15, 2020
Actual Primary Completion Date : June 3, 2021
Actual Study Completion Date : September 30, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
ELISA
ELISA kit detecting the serum AMH level
 Diagnostic Test: ELISA
ELISA kit detecting the serum AMH level
Other Name: experimental group
Chemiluminescence
CLIA method detecting the serum AMH level
 Diagnostic Test: Chemiluminescence
CLIA method detecting the serum AMH level
Other Name: control group


Outcome Measures
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Primary Outcome Measures :
  1. the AMH（CLIA） cutoff value of low and high ovarian response [ Time Frame: the day of oocytes retrieved，about three months after AMH test ]
    the poor ovarian response :the number of retrieved oocyte ≤ 3,the high ovarian response :the number of retrieved oocyte ≥ 15


Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 34-36 hours after hCG trigger，about three months after AMH test ]
    the number of oocytes retrieved after hCG trigger

  2. the serum AMH level [ Time Frame: any day of the menstrual cycle, about three months after study starting ]
    anti-muller hormone


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
infertility females
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639505


Locations
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China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya
Investigators
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Principal Investigator: Fei Gong, PhD Reproductive & Genetic Hospital of CITIC-Xiangya
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT04639505    
Other Study ID Numbers: P2020004
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility