| CTRI Number |
CTRI/2026/03/106004 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out whether follicle-stimulating hormone (FSH) treatment can improve semen parameters in men with idiopathic infertility (APHRODITE Group 2). |
|
Scientific Title of Study
|
Effect of follicle-stimulating hormone therapy in idiopathic male infertility classified as APHRODITE group 2: an open-label randomised controlled superiority trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANISHA POLAKI |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ALL INDIA INSTTIUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Ansari nagar, AIIMS hospital, Department of Obstetric and Gynaecology, ART centre, New delhi
New Delhi
DELHI
110029
India |
| Phone |
08520981213 |
| Fax |
|
| Email |
manishapolaki14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JUHI BHARTI |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTTIUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Ansari nagar, AIIMS hospital, Department of Obstetric and Gynaecology, ART centre, New delhi
New Delhi
DELHI
110029
India |
| Phone |
8527570849 |
| Fax |
|
| Email |
drjuhigeorgian.04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JUHI BHARTI |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTTIUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Ansari nagar, AIIMS hospital, Department of Obstetric and Gynaecology, ART centre, New delhi
New Delhi
DELHI
110029
India |
| Phone |
8527570849 |
| Fax |
|
| Email |
drjuhigeorgian.04@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS DELHI |
| Address |
Ansari nagar, All india institute of medical sciences, New Delhi, Pin: 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR POLAKI MANISHA |
AIIMS DELHI |
ART CENTRE, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, AIIMS NEW DELHI
New Delhi
DELHI |
8520981213
manishapolaki14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N461||Oligospermia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FOLLICLE STIMULATING HORMONE WITH LIFESTYLE MODIFICATIONS |
Participants in the intervention group will receive recombinant follicle-stimulating hormone (rFSH) at a dose of 150 IU administered subcutaneously three times per week for a duration of 3 months, in addition to standard lifestyle counselling. Treatment will be supervised by the study investigators, and adherence will be monitored through monthly follow-up visits. |
| Comparator Agent |
LIFESTYLE MODIFICATIONS ONLY |
Participants in the control group will receive lifestyle modification counselling only, which includes advice on smoking cessation, limiting alcohol intake, weight optimization, regular physical activity, adequate sleep, and stress reduction. Dietary counselling and avoidance of gonadotoxic exposures will also be reinforced. No hormonal therapy will be given in this group. Follow-up assessments will be performed at 3 months. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Couples with male factor infertility as per WHO 2021 semen analysis criteria with normal FSH and testosterone and are willing to provide informed consent. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in semen parameters, including sperm concentration, total sperm motility, and progressive sperm motility
|
baseline and at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
FOR LAB OUTCOMES- WITNIN 4 WEEKS OF LAST FSH INJECTIONS
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |