APHRODITE Group
Conditions
Keywords
Non-obstructive azoospermia (NOA), Idiopathic NOA, Male infertility, Hypogonadism
Brief summary
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
Interventions
OTHERNo intervention
Standard of Care
OTHERhCG + FSH therapy
hCG + FSH therapy with monthly hormone-driven titration (hCG initial \~83 µg SC twice weekly; no preset min/max; target TT \>350-900 ng/dL) + FSH 150 IU SC twice weekly (increase to 150 IU SC three times weekly if 'FSH reset' \<1.5 IU/L); allow anastrozole 1 mg PO daily /letrozole 2.5 mg half tablet alternate day if T/E \<10
Sponsors
Indira IVF Hospital Pvt Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success or Sperm Availability | from randomization through Week 16 via ejaculate or micro-TESE | Sperm Availability for ICSI was defined as the presence of viable sperm suitable for intracytoplasmic sperm injection (ICSI) at any time from randomization through Week 16. Sperm could be obtained either through ejaculate or via microsurgical testicular sperm extraction (micro-TESE). Assessment of sperm availability was performed by a centralized adjudication committee, which was blinded to treatment allocation to ensure objective and unbiased evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Micro-TESE Sperm Retrieval Rate (SSR) | The Micro-TESE Sperm Retrieval Rate (SSR) was assessed during the period from randomization through Week 16. The outcome was determined based on the availability of at least one viable sperm retrieved via microsurgical testicular sperm extraction (micro- | Whether sperm are retrieved during micro-TESE |
| Need for Micro-TESE Surgery | Up to Week 16 | Whether the participant requires micro-TESE |
| Safety / Harms | Week 16 | All adverse events (AE/SAE) related to treatment or procedure |
| ICSI Fertilization Rate | Within the ICSI cycle ≈ Day 1-3 after ICSI | % of injected oocytes that form normal 2PN embryos |
| Blastulation Rate | Day 5-7 after fertilization | % of embryos reaching blastocyst stage |
| Blastocyst Quality | Day 5-7 after fertilization | Grading of blastocysts based on standard morphology criteria |
| Top-Quality Blastocyst Rate | Day 5-7 after fertilization | % of "top-1 quality" blastocysts formed |
| Clinical Pregnancy Rate | ≈ 6-8 weeks after embryo transfer | Presence of gestational sac with cardiac activity on ultrasound |
| Miscarriage Rate | From pregnancy confirmation to 20 weeks gestation | Pregnancy loss before 20 weeks |
| Live Birth | Up to delivery (~9 months after embryo transfer) | Delivery of a live infant |
Countries
India
Contacts
CONTACTVipin Chandra, DGO
Outcome results
None listed