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TerminatedNCT02358733Updated Feb 28, 2019

Use of IMSI in Poor Responders to IVF

An interventional study of Intra-cytoplasmic Sperm Injection and Intra-cytoplasmic Morphologically-selected Sperm Injection in Female Infertility, sponsored by Centro de Infertilidad y Reproducción Humana. Terminated at 1 site in Spain. Open to female participants aged 37 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-02-28.

Sponsored by Centro de Infertilidad y Reproducción Humana · Not applicable, Interventional, and Treatment

Why this study was terminated
DIfficulties with recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
37 Years to 45 Years
Sex
Female
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Study summary

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

Read the 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.

02

Conditions studied

  • Female Infertility

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Keywords

  • POR
  • IMSI
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In context

Infertility, Female

553 studies on the registry are indexed under Infertility, Female; 136 are open to participants now.

This study's enrollment of 10 is below the median of 100 across 377 interventional studies indexed under Infertility, Female.

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Lead sponsor

Centro de Infertilidad y Reproducción Humana is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
37 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • poor ovarian response

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Treatment

    Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)

    Procedure: Intra-cytoplasmic Morphologically-selected Sperm Injection

  • Active comparator
    Control

    Intracytoplasmic sperm injection (ICSI)

    Procedure: Intra-cytoplasmic Sperm Injection

Interventions

  • ProcedureIntra-cytoplasmic Sperm Injection

    Selection of sperm at 400x for sperm injection

  • ProcedureIntra-cytoplasmic Morphologically-selected Sperm Injection

    Selection of sperm at 6000x for sperm injection

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Four to six weeks after embryo transfer

Secondary outcomes

  1. Number of embryos obtained

    Total number of embryos obtained

    Time frame: Two days after egg retrieval

  2. Percentage of cycles with embryo transfer

    Number of cycles reaching embryo transfer per cycle initiated

    Time frame: Two days after egg retrieval

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02358733
Lead sponsor
Centro de Infertilidad y Reproducción Humana
Responsible party
Sponsor
First posted
Feb 9, 2015
Start date
Feb 2015
Primary completion
Jan 2018
Completion
Feb 27, 2019
Last update
Feb 28, 2019

Study contacts

Karinna Lattes, MD
principal investigator · Centro de Infertilidad y Reproducción Humana (CIRH)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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