Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04482751 |
| Other study ID # |
184/2020 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2020 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Azienda Ospedaliero-Universitaria di Modena |
| Contact |
Antonio La Marca |
| Phone |
+390594224671 |
| Email |
antlamarca[@]libero.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
