Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age
IMSIAMA
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 13, 2012
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJanuary 8, 2013
January 1, 2013
9 months
June 13, 2012
January 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implantation rate
Number of embryos implanted in the uterus divided for the number of embryos transferred.
6 weeks after embryo transfer
Study Arms (2)
ICSI group
ACTIVE COMPARATORThis group was provided with conventional intracytoplasmic sperm injection (ICSI). This treatment is routinely used to treat infertility. Sperm selection in the ICSI group is analysed under a magnification of 400x using an inverted microscope.
Intracytoplasmic morphologically selected sperm injection
EXPERIMENTALIntracytoplasmic morphologically selected sperm injection (IMSI) is an established modified ICSI procedure. 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Polycystic ovaries
- Endometriosis
- Gynaecological/medical disorders
- Positive result in a screening for sexually transmitted diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fertility - Assisted Fertilization Center
São Paulo, São Paulo, 04512001, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edson Borges Jr., MD., Ph.D
Fertility - Assisted Fertilization Center and Sapientiae Institute - Educational and Research Center in Assisted Reproduction
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2012
First Posted
June 15, 2012
Study Start
November 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
January 8, 2013
Record last verified: 2013-01