InfertilityNCT04639505
Predictive Value of New AMH Test Method for Ovarian Response
An observational study of Infertility and AMH, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility, AMH
- What is being tested?
- ELISA and Chemiluminescence
- How many people
- 454 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2020to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Adult
Study population: infertility females
Who may be able to join
- The first IVF/ICSI COH cycle;
- the causes of infertility :fallopian tube factors and/or male factors;
Who cannot join
- Endometriosis;
- PCOS;
- Adenomyosis;
- PGT cycle because of the female chromosome abnormality or genetic abnormality;
- FET cycle;
- Malignant tumor patient.
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410008
About this study
Official title: Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI
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.
- Conditions
- Infertility, AMH
- Being tested
- ELISA, Chemiluminescence
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADiagnostic test
Also called experimental group
ELISA kit detecting the serum AMH level
ChemiluminescenceDiagnostic test
Also called control group
CLIA method detecting the serum AMH level
| Study group | Role | What they receive |
|---|---|---|
| ELISA | ELISA kit detecting the serum AMH level Receives: Diagnostic Test: ELISA | |
| Chemiluminescence | CLIA method detecting the serum AMH level Receives: Diagnostic Test: Chemiluminescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the day of oocytes retrieved，about three months after AMH test
Secondary outcomes (2)
Number of oocytes retrieved
the number of oocytes retrieved after hCG trigger
Measured: 34-36 hours after hCG trigger，about three months after AMH test
the serum AMH level
anti-muller hormone
Measured: any day of the menstrual cycle, about three months after study starting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Nov 2020
- Primary completion3 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Gong, PhD, Principal investigator, Reproductive & Genetic Hospital of CITIC-Xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639505
- Sponsor's protocol ID
- P2020004
- Status last verified
- Jan 2022
- First submitted
- 11 Nov 2020
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI
- ClinicalTrials.gov ID
- NCT04639505
- Acronym / sponsor ID
- P2020004
- Conditions
- Infertility, AMH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELISA | – | Diagnostic Test: ELISAELISA kit detecting the serum AMH level |
| Chemiluminescence | – | Diagnostic Test: ChemiluminescenceCLIA method detecting the serum AMH level |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- infertility females
Key inclusion criteria (2 listed)
- The first IVF/ICSI COH cycle;
- the causes of infertility :fallopian tube factors and/or male factors;
Key exclusion criteria (6 listed)
- Endometriosis;
- PCOS;
- Adenomyosis;
- PGT cycle because of the female chromosome abnormality or genetic abnormality;
- FET cycle;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISAAlso: experimental groupELISA kit detecting the serum AMH level | Diagnostic test | ELISA |
| ChemiluminescenceAlso: control groupCLIA method detecting the serum AMH level | Diagnostic test | Chemiluminescence |
Primary outcome
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
2 secondary outcomes
Number of oocytes retrieved
Time frame: 34-36 hours after hCG trigger，about three months after AMH test
the serum AMH level
Time frame: any day of the menstrual cycle, about three months after study starting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Gong, PhD principal investigator
Reproductive & Genetic Hospital of CITIC-Xiangya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and AMH, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the AMH（CLIA） cutoff value of low and high ovarian response (time frame: the day of oocytes retrieved，about three months after AMH test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.