Use of IMSI in Poor Responders to IVF

Centro de Infertilidad y Reproducción Humana

Status: Terminated

Conditions: Female Infertility

Treatments: Procedure: Intra-cytoplasmic Sperm Injection; Procedure: Intra-cytoplasmic Morphologically-selected Sperm Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02358733

CIRH-BROIMSI-2014

2014-003928-50 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 37 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Treatment

Experimental group

Description:

Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)

Treatment:

Procedure: Intra-cytoplasmic Morphologically-selected Sperm Injection

Control

Active Comparator group

Description:

Intracytoplasmic sperm injection (ICSI)

Treatment:

Procedure: Intra-cytoplasmic Sperm Injection