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Use of IMSI in Poor Responders to IVF

Primary Purpose

Female Infertility

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intra-cytoplasmic Sperm Injection
Intra-cytoplasmic Morphologically-selected Sperm Injection
Sponsored by
Centro de Infertilidad y Reproducción Humana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Infertility focused on measuring POR, IMSI

Eligibility Criteria

37 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Infertilidad y Reproducción Humana (CIRH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)

Intracytoplasmic sperm injection (ICSI)

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Percentage of patients presenting with presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound, per cycle initiated

Secondary Outcome Measures

Number of embryos obtained
Total number of embryos obtained
Percentage of cycles with embryo transfer
Number of cycles reaching embryo transfer per cycle initiated

Full Information

First Posted
February 4, 2015
Last Updated
February 27, 2019
Sponsor
Centro de Infertilidad y Reproducción Humana
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1. Study Identification

Unique Protocol Identification Number
NCT02358733
Brief Title
Use of IMSI in Poor Responders to IVF
Official Title
Use of Intra-Cytoplasmic Morphologically Selected Sperm Injection (IMSI) in Poor Responders to In Vitro Fertilization (IVF): a Prospective, Double-blind, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
DIfficulties with recruitment
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
February 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Infertilidad y Reproducción Humana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
Keywords
POR, IMSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Intracytoplasmic sperm injection (ICSI)
Intervention Type
Procedure
Intervention Name(s)
Intra-cytoplasmic Sperm Injection
Intervention Description
Selection of sperm at 400x for sperm injection
Intervention Type
Procedure
Intervention Name(s)
Intra-cytoplasmic Morphologically-selected Sperm Injection
Intervention Description
Selection of sperm at 6000x for sperm injection
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Percentage of patients presenting with presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound, per cycle initiated
Time Frame
Four to six weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Number of embryos obtained
Description
Total number of embryos obtained
Time Frame
Two days after egg retrieval
Title
Percentage of cycles with embryo transfer
Description
Number of cycles reaching embryo transfer per cycle initiated
Time Frame
Two days after egg retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karinna Lattes, MD
Organizational Affiliation
Centro de Infertilidad y Reproducción Humana (CIRH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Infertilidad y Reproducción Humana (CIRH)
City
Barcelona
ZIP/Postal Code
08017
Country
Spain

12. IPD Sharing Statement

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Use of IMSI in Poor Responders to IVF

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