Use of IMSI in Poor Responders to IVF

NCT ID: NCT02358733

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Female Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)

Group Type EXPERIMENTAL

Intra-cytoplasmic Morphologically-selected Sperm Injection

Intervention Type PROCEDURE

Selection of sperm at 6000x for sperm injection

Control

Intracytoplasmic sperm injection (ICSI)

Group Type ACTIVE_COMPARATOR

Intra-cytoplasmic Sperm Injection

Intervention Type PROCEDURE

Selection of sperm at 400x for sperm injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intra-cytoplasmic Sperm Injection

Selection of sperm at 400x for sperm injection

Intervention Type PROCEDURE

Intra-cytoplasmic Morphologically-selected Sperm Injection

Selection of sperm at 6000x for sperm injection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

37 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centro de Infertilidad y Reproducción Humana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karinna Lattes, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Infertilidad y Reproducción Humana (CIRH)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro de Infertilidad y Reproducción Humana (CIRH)

Barcelona, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-003928-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CIRH-BROIMSI-2014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fresh Vs Frozen Surgical Sperm in IVF
NCT03361982 TERMINATED NA
In Vitro Follicle Activation
NCT02496598 TERMINATED NA
ReceptIVFity & Immunology in ART
NCT06709976 ENROLLING_BY_INVITATION