Use of IMSI in Poor Responders to IVF

Female Infertility Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02358733
• Other study ID #: CIRH-BROIMSI-2014
• Secondary ID: 2014-003928-50
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 27, 2019

Study information

• Verified date: February 2019
• Source: Centro de Infertilidad y Reproducción Humana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 27, 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 37 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Procedure:
• Intra-cytoplasmic Sperm Injection
Selection of sperm at 400x for sperm injection
• Intra-cytoplasmic Morphologically-selected Sperm Injection
Selection of sperm at 6000x for sperm injection

Locations

Country	Name	City	State
Spain	Centro de Infertilidad y Reproducción Humana (CIRH)	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Infertilidad y Reproducción Humana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of embryos obtained	Total number of embryos obtained	Two days after egg retrieval
Secondary	Percentage of cycles with embryo transfer	Number of cycles reaching embryo transfer per cycle initiated	Two days after egg retrieval