Clinical trial

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

Name

01/MR/19

Description

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.

Trial arms

Trial start

2019-09-20

Estimated PCD

2023-01-31

Trial end

2023-01-31

Status

Completed

Treatment

150 IU of HMG in patients with age ≤ 35 years

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.

Arms:

Female age ≤ 35 years: 150 IU of HMG

225 IU of HMG in patients with age > 35 years

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.

Arms:

Female age >35 years: 225 IU of HMG

Size

160

Primary endpoint

Number of oocytes retrieved

13-15 days starting from the first day of the cycle

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 160, 'type': 'ACTUAL'}}

Updated at

2023-02-01

1 organization

1 product

1 indication

Organization

Andros Day Surgery Clinic

Product

HMG

Indication

Ovarian Response