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Completed

NCT Number: NCT04168892

Anti-Müllerian Hormone (AMH) Measured With Fully Automated Assay Versus AFC in the Prediction of Ovarian Response

The primary objective of this prospective, observational, multivariate study will be to compare the reliability of automated AMH (measured with Access AMH assay, Beckman-Coulter Diagnostics, USA) with that of antral follicle count (AFC) evaluated ultrasonographically always by the same operator and with the same ultrasound scanner, in terms of the number of oocytes recovered from oocyte sampling in couples subjected to in vitro fertilization.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

ANDROS Day Surgery Clinic, Reproductive Medicine Unit

Palermo, 90144, Italy

About this study

Individual variability in ovarian response to a starting dose of gonadotropins is a well-known aspect during controlled ovarian stimulation (COS) and many efforts have been made for obtaining the personalization of the treatment, identifying different biomarkers that may predict the ovarian response such as age, basal Follicle Stimulating Hormone (FSH), AMH and antral follicle count (AFC). The number of oocytes retrieved is the main expression of ovarian response and it remains a relevant prognostic marker in women undergoing In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) cycles. Consistent evidence shows that an optimal - rather than a maximal - oocyte yield is the preferred achievement after COS when fresh embryo transfer is scheduled. In fact, live birth rates steadily increase when an optimal number of oocytes is collected, whereas low response and hyper-response are associated with lower implantation rates, increased obstetrical risks and, at least when considering hyper response, increased risk of ovarian hyperstimulation syndrome (OHSS) in the fresh cycle. Among the different biomarkers, AMH and AFC seem to have the best performance in predicting ovarian response to exogenous FSH.

Nevertheless, until now, there is often discordance between the AMH level and AFC in clinical practice. In cases of discordance, which indicator should be chosen to individualize the starting dose of gonadotropins? Until now, no direct comparison of the new automated immunoassay of AMH with AFC has been carried out considering the number of retrieved oocytes as primary endpoint.

Who can participate

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

Inclusion criteria

BMI between 18 and 30 kg/m2, basal serum day 3 FSH ≤ 15 IU/l, normal regular menstrual cycles, ranging from 25 to 33 days in length, normal thyroid-stimulating hormone (TSH) and prolactin levels, normal uterine cavity as assessed by hysteroscopy or sonohysterography or three-dimensional ultrasound and presence of both ovaries.

Exclusion criteria

irregular menstrual cycles, severe endometriosis, defined as stage III-IV of the American Society for Reproductive Medicine (ASRM) revised classification, previous ovarian surgery, presence of ovarian cysts, polycystic ovary syndrome, use of hormonal contraception in the previous 3 months and use of gonadotrophins in the previous 3 months, any known metabolic or endocrinological disease

Treatment and study plan

150 IU of HMG in patients with age ≤ 35 years

Drug

The use of a different starting dose, based on the female age, derives from the necessity to control the effect of a variable starting dose on the primary outcome.

225 IU of HMG in patients with age > 35 years

Drug

The use of a different starting dose, based on the female age, derives from the necessity to control the effect of a variable starting dose on the primary outcome.

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 13-15 days starting from the first day of the cycle

    The number of oocytes collected after oocyte retrieval

Secondary outcomes

  1. Cumulative clinical pregnancy rate per patient

    Time frame: 28-32 days after the oocyte retrieval

    The number of clinical pregnancies (gestational sacs with a fetal heartbeat detected at ultrasound 28-32 days after oocyte retrieval) obtained by fresh and frozen embryo transfers per each patient.

Sponsors and collaborators

Lead sponsor

Andros Day Surgery Clinic

Other

Registry information

Official study title

Prospective, Observational, Multivariate Study to Evaluate the Best Predictor of Ovarian Response, Between AMH Measured With Fully Automated Assay and AFC

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2019
Registry last updated
Feb 1, 2023

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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