Use of IMSI in Poor Responders to IVF

Use of Intra-Cytoplasmic Morphologically Selected Sperm Injection (IMSI) in Poor Responders to In Vitro Fertilization (IVF): a Prospective, Double-blind, Randomized, Controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02358733

Enrollment

Registered

2015-02-09

Start date

2015-02-28

Completion date

2019-02-27

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility

Keywords

POR, IMSI

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

37 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026