Predictive Value of New AMH Test Method for Ovarian Response

NCT04639505 | Completed

• 1 other identifier: P2020004
• Study Type: observational
• Target: 454
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; AMH

Outcome Measures

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

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

Secondary Outcomes (2)

• 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

Study Arms (2)

ELISA

ELISA kit detecting the serum AMH level

Diagnostic Test: ELISA

Chemiluminescence

CLIA method detecting the serum AMH level

Diagnostic Test: Chemiluminescence

Interventions

ELISA DIAGNOSTIC_TEST

ELISA kit detecting the serum AMH level

Also known as: experimental group

ELISA

Chemiluminescence DIAGNOSTIC_TEST

CLIA method detecting the serum AMH level

Also known as: control group

Chemiluminescence

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

infertility females

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Infertility

Interventions

Luminescence

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• Fei Gong, PhD

  Reproductive & Genetic Hospital of CITIC-Xiangya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 20, 2020
• Study Start: November 15, 2020
• Primary Completion: June 3, 2021
• Study Completion: September 30, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Locations

CN (1)