LEUPRORELIN ACETATE for Adenomyosis | Infertility

Inclusion criteria

• {"criterion_text":"- Uterine adenomyosis diagnosed on ultrasound scan defined when at least ne of the following features is recognized: (1) heterogeneous myometrium; (2) hypoechoic striation in the myometrium; (3) myometrial anechoic lacunae or cysts; (4) asymmetrical myometrial thickening of the uterine walls."}
• {"criterion_text":"- Couples requiring a cycle of IVF/ICSI meeting the criteria of the Italian law to be included in an ART program."}
• {"criterion_text":"- Good physical and mental health (e.g. no contraindication to the therapeutic regimen for IVF/ICSI, like moderate or severe impairment of renal or hepatic function etc.)."}
• {"criterion_text":"- First or second IVF/ICSI attempt."}
• {"criterion_text":"- Absence of severe premature ovarian insufficiency defined by antral follicle count < 8 and AMH < 1ng/ml."}
• {"criterion_text":"- The female partner is ≥18 and < 42 years of age."}
• {"criterion_text":"- The female partner has a BMI <30."}
• {"criterion_text":"- Both partners are willing and able to provide written informed consent."}

Exclusion criteria

• {"criterion_text":"- Concurrent and/or recent involvement in other studies likely to interfere with the intervention within the previous 3 months of study enrolment."}
• {"criterion_text":"- Other potential causes of implantation failure: leiomyoma, actual hydrosalpinx, malformed uterus (unicornis, bicornis, septate, duplex), antiphospholipid syndrome"}
• {"criterion_text":"- A prior history of endometrial ablation, endometrial polyps, hydrosalpinx, smocking habits, known endometriosis stage III-IV, abnormal uterine bleeding of unknown cause."}
• {"criterion_text":"- Uterine fibroids (untreated FIGO Type 0-I-II and type III-IV fibroids > 3 cm)"}
• {"criterion_text":"- Use of GnRH analogues within previous 3 months."}
• {"criterion_text":"- Extreme severe male factor infertility (sperm count < 1 x 106/ml, use or surgically retrieved spermatozoa)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Couples who in the opinion of the researcher would be unable to give fully informed consent to the study."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Primary outcome defined in main objective: Number of live birth after ART attempt defined as delivery of one or more live-born infant at >22 weeks of gestation in infertile women with adenomyosis vs. infertile women without adenomyosis."}

Secondary endpoints

• {"endpoint_text":"- 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, preeclampsia, cesarean section, fetal malformation, SGA, low birth weight and postpartum haemorrhage).","definition_or_measurement_approach":"Measured by pregnancy and neonatal outcomes: rates of preterm delivery, pre-eclampsia, cesarean section, fetal malformation, small for gestational age (SGA), low birth weight and postpartum haemorrhage; comparisons between women with adenomyosis vs without and by COH protocol."}
• {"endpoint_text":"- Secondary in-vitro sub-studies: Stimulated (P and DNG) markers of decidualization (osteopontin, prolactin) in relation to ART success in women with and without A. Immune system cell population and relative cytokines, the frequency of immune system cells, the interleukin profile, cell activity, specific receptors of pregnancy hormone involved in T cell activity in women with A in comparison to healthy subjects.","definition_or_measurement_approach":"Measured by in-vitro assays of decidualization markers (osteopontin, prolactin), immune cell population counts, cytokine and interleukin profiling, and receptor analyses; correlated with ART success metrics."}

Italy

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

04-04-2025

Processing Time Days

248

Number Of Sites

2

Number Of Participants

500

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Di Modena

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy