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OpenTrials
Completed

NCT Number: NCT04639505

Predictive Value of New AMH Test Method for Ovarian Response

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ELISA

Diagnostic Test

ELISA kit detecting the serum AMH level

Other names: experimental group

Chemiluminescence

Diagnostic Test

CLIA method detecting the serum AMH level

Other names: control group

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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