Effect of follicle-stimulating hormone therapy in idiopathic male infertility classified as APHRODITE group 2: an open-label randomised controlled superiority trial

This is a parallel-group, open-label, randomised controlled superiority trial conducted at the ART Centre, Department of Obstetrics & Gynaecology, AIIMS New Delhi. The study aims to evaluate whether follicle-stimulating hormone (FSH) therapy, given in addition to lifestyle modification, results in greater improvement in semen parameters compared with lifestyle modification alone in infertile men classified as APHRODITE Group 2 (idiopathic oligo-astheno-teratozoospermia with normal FSH and testosterone levels).

A total of 60 participants (30 per group), aged 21–45 years and meeting WHO 2021 semen analysis criteria, will be randomised in a 1:1 ratio using a computer-generated sequence with allocation concealment through sealed opaque envelopes.

Group A will receive recombinant FSH 150 IU subcutaneously three times weekly for 12 weeks along with lifestyle modification counselling, while Group B will receive lifestyle modification counselling alone with no hormonal therapy. All participants will undergo monthly safety monitoring, and semen analysis and hormonal profile will be reassessed after 12 weeks.

The primary outcome is change in semen parameters (sperm concentration, total motility, and progressive motility) from baseline to 12 weeks. Secondary outcomes include embryological outcomes in IVF/ICSI cycles (fertilisation rate, cleavage rate, blastulation rate, and number of good-quality embryos), clinical pregnancy rate, success rate of surgical sperm retrieval, and adverse effects of FSH therapy.

The study is expected to generate evidence on the role of FSH therapy as an adjunct to lifestyle modification in APHRODITE Group 2 men and its potential impact on reproductive outcomes.