Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

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.

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

37 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertility - Assisted Fertilization Center

São Paulo, 04512001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracytoplasmic Sperm Injection (ICSI)

Procedure

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.

Intracytoplasmic morphologically selected sperm injection

Procedure

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.

Primary outcomes

Implantation rate

Time frame: 6 weeks after embryo transfer

Number of embryos implanted in the uterus divided for the number of embryos transferred.

Sponsors and collaborators

Lead sponsor

Sapientiae Institute

Other

Registry information

Official study title

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

Acronym: IMSIAMA

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 15, 2012
Registry last updated: Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed