Women with transvaginal ultrasound (TV-US)-based diagnosis of adenomyosis and women without adenomyosis but with similar baseline reproductive risks MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Enantone
Product Code: [-]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LEUPRORELINA ACETATO
Current Sponsor code: Leuprorelina Acetato
Concentration unit: mg milligr
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adenomyosis of the uterus defined with at least one of the following features: (1) heterogeneous myometrium; (2) hypoechoic striation in the myometrium; (3) myometrial anechoic lacunae or cysts; (4) asymmetrical myometrial thickening of the uterine walls. Couples who are undergoing a cycle of IVF/ICSI, where a cycle is defined as egg collection following ovarian stimulation. First or second IVF or ICSI attempt. Absence of severe premature ovarian insufficiency defined by antral follicle count =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within the previous 3 months of study enrolment. Other potential causes of implantation failure: in situ leiomyoma, hydrosalpinx, malformed uterus (unicornis, bicornis, septate, duplex), antiphospholipid syndrome Uterine fibroids (untreated FIGO Type 0-I-II and type III-IV fibroids > 3 cm) Use of GnRH analogues within previous 3 months. Extremely severe male factor infertility (sperm count < 1x 106/ml, use o surgically retrieved spermatozoa) Positive plasma viral load for human immunodeficiency virus(HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) for one (or both) in the couple during the year before inclusion Couples unable to give fully informed consent to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively investigate the association of Adenomyosis with fertility outcomes in relation to COH protocols for ART (long or ultra-long protocol) with a preventive high-dose anti-inflammatory progestin such as dienogest (DNG).;Secondary Objective: To evaluate the association of COH (Controlled Ovarian Hyperstimulation) protocols for ART (long or ultra-long protocol) with a high-dose preventive anti-inflammatory progestogen such as DNG with pregnancy and neonatal outcomes (preterm delivery, pre-eclampsia, cesarean section, fetal malformation, SGA, low birth weight and postpartum haemorrhage).;Primary end point(s): Number of live births after ART (delivery of one or more live-born infant at >22 weeks of gestation).;Timepoint(s) of evaluation of this end point: >22 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Uterine volume changes by TV-US measurements at baseline and at time of COH onset, occurrence of poor responders, implantation and clinical pregnancy rate. Moreover, the rate of preterm delivery, pre-eclampsia, small for gestational age (500 ml) will be calculated.;Timepoint(s) of evaluation of this end point: 24 month | — |
Countries
Italy
Contacts
Public ContactClinical Trials Quality Team
Azienda Ospedaliero-Universitaria di Modena
Outcome results
None listed