Use of IMSI in Poor Responders to IVF

Not Applicable

Terminated

• Conditions: Female Infertility
• Interventions: Procedure: Intra-cytoplasmic Morphologically-selected Sperm Injection; Procedure: Intra-cytoplasmic Sperm Injection

• Registration Number: NCT02358733
• Lead Sponsor: Centro de Infertilidad y Reproducción Humana

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-09
• Primary Completion: 2018-01
• Status Verified: 2019-02
• Study Completion: 2019-02-27
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Intra-cytoplasmic Morphologically-selected Sperm Injection	Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)
Control	Intra-cytoplasmic Sperm Injection	Intracytoplasmic sperm injection (ICSI)

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	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

Secondary Outcome Measures

Name	Time	Method
Number of embryos obtained	Two days after egg retrieval	Total number of embryos obtained
Percentage of cycles with embryo transfer	Two days after egg retrieval	Number of cycles reaching embryo transfer per cycle initiated

Trial Locations

Locations (1)

Centro de Infertilidad y Reproducción Humana (CIRH); 🇪🇸 Barcelona, Spain