LUTROPIN ALFA for Infertility | Tubal factor infertility | Male factor infertility | Idiopathic infertility

Inclusion criteria

• {"criterion_text":"- 1. AFC of at least 5 in the 3 months prior to the study cycle"}
• {"criterion_text":"- 2. Basal AMH levels of at least 1 ng/ml in the 3 months prior to the study cycle"}
• {"criterion_text":"- 3. Age 25-38 at the moment of the study cycle"}
• {"criterion_text":"- 4. D3 Basal LH: 1-6 IU/L in the 3 months prior to the study cycle"}
• {"criterion_text":"- 5. D3 Basal FSH: < 8 IU/L in the 3 months prior to the study cycle"}
• {"criterion_text":"- 6. D3 Estradiol < 70 pg/ml in the 3 months prior to the study cycle"}
• {"criterion_text":"- 7. Willing to participate"}
• {"criterion_text":"- 8. Capable to understand and follow the study procedure"}
• {"criterion_text":"- 9. eumenorrheic women with low LH levels candidate to IVF/ICSI cycle for tubal factor, male factor or for idiopathic infertility"}
• {"criterion_text":"- 10. Acceptance and signature of the informed consent"}

Exclusion criteria

• {"criterion_text":"- 1. PCOS patients according to Rotterdam’s criteria"}
• {"criterion_text":"- 2. Patients with irregular cycles (shorter than 25 days or longer than 35 days)"}
• {"criterion_text":"- 3. Patients already treated with LH priming"}
• {"criterion_text":"- 4. Patients planning to undergo duo/double stimulation"}
• {"criterion_text":"- 5. Patients with ASRM Stage III or IV endometriosis"}
• {"criterion_text":"- 6. Patients with prior surgery significantly affecting ovary (ie ovariectomy, cystectomy significantly reducing ovarian volume or others) as assessed by the responsible gynecologist"}
• {"criterion_text":"- 7. Previous cycle with less than 4 oocytes recovered"}
• {"criterion_text":"- 8. Patients treated with hormones in the 3 months before the study"}
• {"criterion_text":"- 9. Patients with an already known endocrinological disease including hypothyroidism (defined by TSH < 4 mIU/L), adrenocortical deficiency (ACTH stimulation test (250 mcg) with basal cortisol <3 mcg or, if basal cortisol is 3-18 mcg serum level, cortisol serum level 30 minutes after the stimulation test <18 mcg) and hyperprolactinemia (PLR > 25mcg/l)"}
• {"criterion_text":"- 10. previous episode of OHSS or exuberant ovarian response to gonadotropins"}
• {"criterion_text":"- 11. hypersensitivity to the study drug"}
• {"criterion_text":"- 12. contraindication for pregnancy"}
• {"criterion_text":"- 13. porphyria or a family history of porphyria"}
• {"criterion_text":"- 14. history of ovarian torsion"}
• {"criterion_text":"- 15. BMI > 30 kg/m2"}
• {"criterion_text":"- 16. ovarian enlargement or ovarian cyst"}
• {"criterion_text":"- 17. gynecological bleeding of unknown origin"}
• {"criterion_text":"- 18. history of ovarian, breast or endometrial cancer."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study will be to confirm that the pre-treatment with rhLH at the dose of 187.5 IU/day for 60 days may improve ovarian reserve as indicated by an increase in basal AMH.","definition_or_measurement_approach":"Change from baseline in basal AMH after 60 days of rhLH 187.5 IU/day pre-treatment (AMH measured at baseline and after 60 days)."}

Secondary endpoints

• {"endpoint_text":"- Change of AFC after 30/60 days","definition_or_measurement_approach":"Change from baseline in antral follicle count (AFC) measured at 30 days and 60 days."}
• {"endpoint_text":"- Change of AMH after 30 days","definition_or_measurement_approach":"Change from baseline in basal AMH measured after 30 days."}
• {"endpoint_text":"- Ovarian response","definition_or_measurement_approach":"Ovarian response to controlled ovarian stimulation in IVF/ICSI cycles: number of follicles >16 mm at end of stimulation, number of retrieved oocytes, FORT index (follicles to oocyte ratio), number of mature oocytes."}
• {"endpoint_text":"- Evaluate the safety of rLH","definition_or_measurement_approach":"Assessment of safety throughout treatment period (adverse events monitoring)."}
• {"endpoint_text":"- cycles discontinued/cancelled before rhCG administration","definition_or_measurement_approach":"Count and reasons for cycles discontinued or cancelled prior to rhCG triggering."}
• {"endpoint_text":"- percent of missed transfer of fresh embryos","definition_or_measurement_approach":"Proportion of cycles where fresh embryo transfer was not performed."}
• {"endpoint_text":"- implantation rate","definition_or_measurement_approach":"Implantation rate as per routine clinical definition (not further specified in source)."}
• {"endpoint_text":"- biochemical pregnancy rate","definition_or_measurement_approach":"Biochemical pregnancy rate (not otherwise defined in source)."}
• {"endpoint_text":"- clinical pregnancy rate","definition_or_measurement_approach":"Clinical pregnancy rate (not otherwise defined in source)."}
• {"endpoint_text":"- early and late OHSS rate","definition_or_measurement_approach":"Rate of OHSS onset early (≤9 days after triggering) and late (12–17 days after triggering) according to Golan’s Classification System."}
• {"endpoint_text":"- miscarriage rate","definition_or_measurement_approach":"Miscarriage rate (not otherwise defined in source)."}
• {"endpoint_text":"- preterm birth rate","definition_or_measurement_approach":"Preterm birth rate (not otherwise defined in source)."}
• {"endpoint_text":"- low birth weight rate","definition_or_measurement_approach":"Low birth weight rate (not otherwise defined in source)."}
• {"endpoint_text":"- congenital anomalies rate","definition_or_measurement_approach":"Rate of congenital anomalies (not otherwise defined in source)."}
• {"endpoint_text":"- gestational age at delivery","definition_or_measurement_approach":"Gestational age at delivery (not otherwise defined in source)."}
• {"endpoint_text":"- mean neonatal weight","definition_or_measurement_approach":"Mean neonatal weight (not otherwise defined in source)."}

Italy

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

12-09-2025

Processing Time Days

325

Number Of Sites

3

Number Of Participants

84

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Di Modena

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Merck Healthcare KGaA","duties_or_roles":"Source of monetary support","organisation_type":""}