Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age (IMSIAMA)

Sapientiae Institute

Status: Completed

Conditions: Female Infertility

Treatments: Procedure: Intracytoplasmic sperm injection (ICSI); Procedure: Intracytoplasmic morphologically selected sperm injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01620346

Sapi2012_1

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Female

Ages: 37+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

66 participants in 2 patient groups

ICSI group

Active Comparator group

Description:

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.

Treatment:

Procedure: Intracytoplasmic sperm injection (ICSI)

Intracytoplasmic morphologically selected sperm injection

Experimental group

Description:

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.

Treatment:

Procedure: Intracytoplasmic morphologically selected sperm injection