Sponsor study identifier
observational
454
1 country
1
Study Start
November 15, 2020
Actual (reported)Primary Completion
June 3, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 11, 2020
Actual (reported)November 15, 2020
Actual (reported)November 20, 2020
Actual (reported)June 3, 2021
Actual (reported)September 30, 2021
Actual (reported)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
Number of oocytes retrieved
34-36 hours after hCG trigger,about three months after AMH test
the serum AMH level
any day of the menstrual cycle, about three months after study starting
ELISA kit detecting the serum AMH level
CLIA method detecting the serum AMH level
ELISA kit detecting the serum AMH level
CLIA method detecting the serum AMH level
infertility females
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410008, China
Fei Gong, PhD
Reproductive & Genetic Hospital of CITIC-Xiangya
454 participants (actual enrollment reported by the registry).
First Submitted
November 11, 2020
First Posted
November 20, 2020
Study Start
November 15, 2020
Actual (reported)Autologous Platelet-rich Plasma to Improve Responsiveness and Embryo Quality in Patients With Poor Ovarian Response
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Primary Completion
June 3, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)Last Updated
January 13, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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