The Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa (ACO)

An Observational Single Center Study to Identify the Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa (ACO Study)

The objective of this study is to evaluate the trend of serum AMH during IVF (in vitro fertilization) cycles, in particular the possible relationship between the dynamics of AMH and the early or normal response to therapies for controlled ovarian stimulation with corifollitropin alfa. The secondary objective is to study the association between the number of follicles equal to or greater than 17 mm on the eighth day of ovarian stimulation and the decline in AMH, and to assess the predictability of the need to add additional therapies after the first week of stimulation ovarian.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: Corifollitropin alfa

Detailed Description

The study is observational and it is monocentric, and it will involve 80 patients. Patients' data, extrapolated from the medical records of the Department of Reproductive Medicine in the Policlinico Hospital in Modena, will be collected in an internal database for analysis. The inclusion criteria for the population included in the study will be: 1) basal serum FSH concentration below 20 UI/L; 2) age between 18 and 46 years; 3) body weight > 60 kg; 4) use of corifollitrofin alpha for ovarian stimulation. The following parameters will be evaluated: the age of the patients, their weight, their body mass index (BMI), duration of infertility, cycle characteristics; basal (day 2) AMH, AFC measurement, basal estradiol, basal progesterone, basal FSH, basal LH, and those same values on day 5 and day 8 of ovarian stimulation; follicles ≥ 17 mm on day 8, type of gonadothropin further added, days of stimulation with the further gonadothropin and its units per day, AMH on trigger day and the number of oocytes retrieved. The confidentiality of the informations will be guaranteed by anonymized data analysis. All the data are commonly recorded in our clinical practice.

The observed period will be of 12 months. The date of conclusion of the study, after favorable opinion of the Ethics Committee and the authorization of the Company Management, is scheduled for June 2021.

To guarantee the consent and the information of the patients involved in the study, the Information Sheet and the relative Consent Form are attached. We consider appropriate to inform the General Physician of the enlisted patients about the study: the Information Letter for the General Physician is therefore attached.

Variables/Time Points of Interest

The variables which will be recorded on cycle day 2 of a spontaneous menstruation (stimulation day 1 with Corifollitropin alfa) are: woman's age (years), weight (kg), body-mass-index (kg/m2), duration of infertility (months), cycle length (in days, by patient recall), cycle regularity (yes/no; deviation of > 5 days from two consecutive cycles is considered an irregular cycle), total number of antral follicles (2-10 mm) in both ovaries (AFC) measured by a transvaginal scan and serum AMH (ng/ml), oestradiol, progesterone, FSH and LH.

Patients will return every two days to the clinic for a transvaginal ultrasound from stimulation day 5 up to and including the day of hCG. Serum hormone concentrations (FSH, LH, oestradiol, progesterone and AMH) will be measured on stimulation days 5 and 8 and on the day of hCG.

All hormones reported above will be measured in the central lab of the ospital as per routine practice. Remaining serum will be used for the AMH assay. The measurement of the AMH will ber profrmed in the ObGyn University research Lab.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Italy
  • Modena - MO
    • Modena, Modena - MO, Italy, 41123
      • Recruiting
      • Policlinico di Modena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 46 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Infertile patients

Description

Inclusion Criteria:

• basal serum FSH concentration below 20 UI/L
• age between 18 and 46 years
• body weight > 60 kg
• use of corifollitrofin alpha for ovarian stimulation.

Exclusion criteria:

• contraindications to IVF
• irregular menstrual cycles

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infertile women; the group consists of 80 infertile patients undergoing IVF	Drug: Corifollitropin alfa; AMH will be measured during ovarian stimulation with corifollitropin alfa; Other Names: no other interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in serum Antimullerian Hormone (AMH) levels during ovarian stimulation	Serum concentrations of AMH will be measured during ovarian stimulation with corifollitropin alfa.	AMH will be measured at day 2, day 5, day 8 and the last day (usually day 11) of ovarian stimulation

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Modena

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 18, 2020
• First Posted (ACTUAL): July 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 184/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No