Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive
Не е приложима фаза (напр. обсервационно)
Заболявания:
APHRODITE Group
Спонсор: Indira IVF Hospital Pvt Ltd
Налично на:
БГ
Обобщение
The goal of this clinical trial is to determine whether short-term gonadotropin therapy (hCG + FSH) can increase sperm availability for ICSI in men with idiopathic non-obstructive azoospermia (NOA) and hypogonadism. The main questions it aims to answer are:
Does hormonal optimization improve the likelihood of obtaining usable sperm (via ejaculate or micro-TESE) by Week 16? Does hormonal therapy reduce the need for micro-TESE or improve downstream embryological and clinical outcomes?
Because there is a comparison group, researchers will compare hCG + FSH hormonal therapy with standard-of-care (no gonadotropins) to see if hormonal optimization increases sperm retrieval success and decreases surgical reliance.
Participants will:
Undergo baseline hormonal and semen testing Be randomized to either hormonal therapy or standard-of-care If in the hormonal arm: receive hCG and FSH with monthly dose titration and aromatase inhibitors if indicated Provide semen samples at Weeks 12 and 16 Undergo micro-TESE if no ejaculated sperm are found (timing per protocol) Complete safety assessments and follow-up through Week 16
Кой може да участва
Inclusion Criteria:
\- Idiopathic NOA; hypogonadal (TT \<350 ng/dL on two fasting morning tests); FSH ≥7.6 IU/L (APHRODITE Group 3: 7.6-12.0 IU/L; Group 4: \>12.0 IU/L).
Exclusion Criteria:
cryptorchidism, chemo/radiation, genetic NOA (e.g., AZFa/complete AZFb), testicular trauma/torsion, post-orchitis. prior micro-TESE within 12 months; recent gonadotropin therapy (\<6 months); uncontrolled endocrine disease; active malignancy; severe liver disease; polycythemia (Hct\>50%); inability to comply. Varicocele\>= Grade 3