NCT02358733

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

February 4, 2015

Last Update Submit

February 27, 2019

Conditions

Female Infertility

Keywords

PORIMSI

Outcome Measures

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

    Four to six weeks after embryo transfer

Secondary Outcomes (2)

  • Number of embryos obtained

    Two days after egg retrieval

  • Percentage of cycles with embryo transfer

    Two days after egg retrieval

Study Arms (2)

Treatment

EXPERIMENTAL

Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)

Procedure: Intra-cytoplasmic Morphologically-selected Sperm Injection

Control

ACTIVE COMPARATOR

Intracytoplasmic sperm injection (ICSI)

Procedure: Intra-cytoplasmic Sperm Injection

Interventions

Intra-cytoplasmic Sperm InjectionPROCEDURE

Selection of sperm at 400x for sperm injection

Control
Intra-cytoplasmic Morphologically-selected Sperm InjectionPROCEDURE

Selection of sperm at 6000x for sperm injection

Treatment

Eligibility Criteria

Age37 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • poor ovarian response

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Infertilidad y Reproducción Humana (CIRH)

Barcelona, 08017, Spain

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Karinna Lattes, MD

    Centro de Infertilidad y Reproducción Humana (CIRH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 9, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2018

Study Completion

February 27, 2019

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations

ES(1)