A study to find out whether follicle-stimulating hormone (FSH) treatment can improve semen parameters in men with idiopathic infertility (APHRODITE Group 2).

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106004

Enrollment

Registered

2026-03-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N461- Oligospermia

Interventions

Intervention1: FOLLICLE STIMULATING HORMONE WITH LIFESTYLE MODIFICATIONS: Participants in the intervention group will receive recombinant follicle-stimulating hormone (rFSH) at a dose of 150 IU admini

Eligibility

Inclusion criteria

Inclusion criteria: Couples with male factor infertility as per WHO 2021 semen analysis criteria with normal FSH and testosterone and are willing to provide informed consent.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Change in semen parameters, including sperm concentration, total sperm motility, and progressive sperm motility Timepoint: baseline and at 12 weeks	—

Secondary

Measure	Time frame
1. Laboratory outcomes in assisted reproductive cycles, assessed in IVF/ICSI cycles initiated within 4 weeks after completion of FSH therapy, including: o Fertilisation rate o Cleavage rate o Number of good-quality embryos o Blastulation rate 2. Clinical reproductive outcomes: Clinical pregnancy rate, defined as the presence of an intrauterine gestational sac with fetal cardiac activity on transvaginal ultrasonography. 3. SSR success rates 4. Adverse events Timepoint: FOR LAB OUTCOMES- WITNIN 4 WEEKS OF LAST FSH INJECTIONS	—

Measure

Time frame

1. Laboratory outcomes in assisted reproductive cycles, assessed in IVF/ICSI cycles initiated within 4 weeks after completion of FSH therapy, including: o Fertilisation rate o Cleavage rate o Number of good-quality embryos o Blastulation rate 2. Clinical reproductive outcomes: Clinical pregnancy rate, defined as the presence of an intrauterine gestational sac with fetal cardiac activity on transvaginal ultrasonography. 3. SSR success rates 4. Adverse events Timepoint: FOR LAB OUTCOMES- WITNIN 4 WEEKS OF LAST FSH INJECTIONS

—

Countries

India

Contacts

Public ContactDR JUHI BHARTI

ALL INDIA INSTTIUTE OF MEDICAL SCIENCES, NEW DELHI

drjuhigeorgian.04@gmail.com8527570849

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026