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Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01620346
Acronym
IMSIAMA
Enrollment
66
Registered
2012-06-15
Start date
2011-11-30
Completion date
2012-08-31
Last updated
2013-01-08

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

Conditions

Female Infertility

Keywords

advanced maternal age, infertility, IMSI, ICSI, implantation

Brief summary

The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI). This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33). The groups were compared with regard to fertilization rate, percentage of high-quality embryos, implantation, pregnancy and miscarriage rates.

Interventions

ICSI is routinely used to treat couples with infertility. Sperm selection in the ICSI group was analysed under a magnification of 400x using an inverted microscope. ICSI was performed in a micro-injection dish prepared with 4 µL droplets of buffered medium (Global® w/HEPES, LifeGlobal, Connecticut, USA) and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.

IMSI is an established modified ICSI procedure that used an unstained real-time observation of spermatozoa under high-magnification. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection.

Sponsors

Sapientiae Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
37 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Good physical and mental health * Advanced maternal age (≥ 37 years old) * Regular menstrual cycles of 25-35 days * Normal basal FSH and LH levels * Body mass index less than 30 kg/m2 * Presence of both ovaries * Intact uterus * No hormone therapy for at least 60 days preceding the study

Exclusion criteria

* Polycystic ovaries * Endometriosis * Gynaecological/medical disorders * Positive result in a screening for sexually transmitted diseases

Design outcomes

Primary

MeasureTime frameDescription
Implantation rate6 weeks after embryo transferNumber of embryos implanted in the uterus divided for the number of embryos transferred.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026