Use of IMSI in Poor Responders to IVF

February 27, 2019 updated by: Centro de Infertilidad y Reproducción Humana

Use of Intra-Cytoplasmic Morphologically Selected Sperm Injection (IMSI) in Poor Responders to In Vitro Fertilization (IVF): a Prospective, Double-blind, Randomized, Controlled Trial

This is a pilot study which aims to determine the role of IMSI in poor responders.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study which aims to determine the role of IMSI over ICSI in poor responders to IVF, without a background of teratozoospermia.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08017
        • Centro de Infertilidad y Reproducción Humana (CIRH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

37 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • poor ovarian response

Exclusion Criteria:

  • body mass index (BMI) ≥ 30 kg/m2
  • presence of endocrinopathies (e.g., diabetes, hyperprolactinemia, hypothyroidism)
  • altered karyotype or documented genetic defects in one or both partners
  • history of chronic, autoimmune or metabolic diseases
  • altered meiosis in testicular biopsy or altered sperm-FISH
  • teratozoospermia
  • participation, simultaneously or within the previous 6 months, in another clinical trial with medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)
Procedure: Intra-cytoplasmic Morphologically-selected Sperm Injection
Selection of sperm at 6000x for sperm injection
Active Comparator: Control
Intracytoplasmic sperm injection (ICSI)
Procedure: Intra-cytoplasmic Sperm Injection
Selection of sperm at 400x for sperm injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: Four to six weeks after embryo transfer
Percentage of patients presenting with presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound, per cycle initiated
Four to six weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of embryos obtained
Time Frame: Two days after egg retrieval
Total number of embryos obtained
Two days after egg retrieval
Percentage of cycles with embryo transfer
Time Frame: Two days after egg retrieval
Number of cycles reaching embryo transfer per cycle initiated
Two days after egg retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Infertilidad y Reproducción Humana

Investigators

  • Principal Investigator: Karinna Lattes, MD, Centro de Infertilidad y Reproducción Humana (CIRH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

February 27, 2019

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRH-BROIMSI-2014
  • 2014-003928-50 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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