Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

NCT ID: NCT01620346

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-08-31

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.

Conditions

Female Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ICSI group

This 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.

Group Type: ACTIVE_COMPARATOR

Intracytoplasmic sperm injection (ICSI)

Intervention Type: 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

Intracytoplasmic 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.

Group Type: EXPERIMENTAL

Intracytoplasmic morphologically selected sperm injection

Intervention Type: 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.

Interventions

Intracytoplasmic sperm injection (ICSI)

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.

Intervention Type: PROCEDURE

Intracytoplasmic morphologically selected sperm injection

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sapientiae Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edson Borges Jr., MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fertility - Assisted Fertilization Center and Sapientiae Institute - Educational and Research Center in Assisted Reproduction

Locations

Fertility - Assisted Fertilization Center

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Sapi2012_1

Identifier Type: -

Identifier Source: org_study_id