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CompletedNCT04639505Updated Jan 13, 2022

Predictive Value of New AMH Test Method for Ovarian Response

An observational study in Infertility and AMH, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Completed at 1 site in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
454
Ages
20 Years to 45 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Infertility
  • AMH

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03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 454 is above the median of 200 across 592 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

infertility females

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The first IVF/ICSI COH cycle;
  • the causes of infertility :fallopian tube factors and/or male factors;

Exclusion criteria

Exclusion Criteria:

  • Endometriosis;
  • PCOS;
  • Adenomyosis;
  • PGT cycle because of the female chromosome abnormality or genetic abnormality;
  • FET cycle;
  • Malignant tumor patient.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
454 participants (actual)
Patient registry
No

Groups and cohorts

  • ELISA

    ELISA kit detecting the serum AMH level

    Diagnostic Test: ELISA

  • Chemiluminescence

    CLIA method detecting the serum AMH level

    Diagnostic Test: Chemiluminescence

Interventions

  • Diagnostic testELISA

    ELISA kit detecting the serum AMH level

    Also known as: experimental group

  • Diagnostic testChemiluminescence

    CLIA method detecting the serum AMH level

    Also known as: control group

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: the day of oocytes retrieved，about three months after AMH test

Secondary outcomes

  1. Number of oocytes retrieved

    the number of oocytes retrieved after hCG trigger

    Time frame: 34-36 hours after hCG trigger，about three months after AMH test

  2. the serum AMH level

    anti-muller hormone

    Time frame: any day of the menstrual cycle, about three months after study starting

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Study locations

1 site
  • Reproductive & Genetic Hospital of CITIC-XIANGYA
    Changsha, Hunan 410008, China
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Jun 2021, 6 months.

Of 209 non-industry observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 100. This study's 6 months is below that.

Counting every sponsor, half of 242 studies reached it within 39 months; a quarter within 16 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 11, 2020
First posted
Nov 20, 2020
StartActual
Nov 15, 2020
Primary completionActual
Jun 3, 2021
CompletionActual
Sep 30, 2021
Last update
Jan 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04639505
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
Nov 20, 2020
Start date
Nov 15, 2020
Primary completion
Jun 3, 2021
Completion
Sep 30, 2021
Last update
Jan 13, 2022

Study contacts

Fei Gong, PhD
principal investigator · Reproductive & Genetic Hospital of CITIC-Xiangya

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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