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

S

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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