TO EVALUATE WHETHER PATIENTS WITH SEVERE MALE FACTOR INFERTILITY WILL BENEFIT FROM A NEW SPERM SELECTION PROCEDURE KNOWN AS PHYSIOLOGIC ICSI (A MODIFIED ICSI PROCEDURE)

THE EFFECTIVENESS OF USING â??PHYSIOLOGIC ICSIâ?? IN PATIENTS WITH SEVERE MALE FACTOR INFERTILITY

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003209

Enrollment

150

Registered

2012-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Infertility

Interventions

Intervention1: Physiologic ICSI: Sperm selection using PICSI dish(which contain hyaluronan)will be done and the selected sperms (which are mature) will be injected in to the oocytes. Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 1. Severe male factor infertility (concentration 1- 10 million/ ml ) and /or motility- less than 30 percentage, morphology less than 4 percentage normal sperms) 1. Female partner less than or equal to 37 years 2. Female partner with more than three dominant follicles by ultrasonography on the day of hCG.

Exclusion criteria

Exclusion criteria: 1. Females with significant pelvic pathology like fibroid, moderate to severe endometriosis, hydrosalpinx. 2. Female partner with baseline follicle stimulating hormone (FSH) level more than 12 IU/l and/ or Anti mullerian Hormone (AMH) level less than2.2 ng/ ml 3. Surgically retrieved sperm.

Design outcomes

Secondary

Measure	Time frame
Embryo quality Clinical pregnancy rate Miscarriage rate Timepoint: 3days- 12 weeks	—

Primary

Measure	Time frame
Fertilization rateTimepoint: 1 day	—

Countries

India

Contacts

Public ContactDr. Preetha. P. R

Christian Medical College, Vellore

drtkaleyamma@gmail.com04162283301

Outcome results

None listed

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