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Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

Not Applicable
Completed
Conditions
Female Infertility
Registration Number
NCT01620346
Lead Sponsor
Sapientiae Institute
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
66
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Implantation rate6 weeks after embryo transfer

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Fertility - Assisted Fertilization Center

🇧🇷

São Paulo, Brazil

Fertility - Assisted Fertilization Center
🇧🇷São Paulo, Brazil

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