Female InfertilityNCT02358733
Use of IMSI in Poor Responders to IVF
A study testing Intra-cytoplasmic Sperm Injection and Intra-cytoplasmic Morphologically-selected Sperm Injection in people with Female Infertility, run by Centro de Infertilidad y Reproducción Humana at 1 site in Spain.
Trial summary
This is a pilot study which aims to determine the role of IMSI in poor responders. Read more about this study
- Who is it for?
- Ages 37 to 45 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- Intra-cytoplasmic Sperm Injection and Intra-cytoplasmic Morphologically-selected Sperm Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to 27 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- poor ovarian response
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Centro de Infertilidad y Reproducción Humana (CIRH)
Barcelona, 08017
About this study
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
This is a pilot study which aims to determine the role of IMSI in poor responders.
Read the 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.
- Conditions
- Female Infertility
- Being tested
- Intra-cytoplasmic Sperm Injection, Intra-cytoplasmic Morphologically-selected Sperm Injection
- Keywords
- POR, IMSI
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-cytoplasmic Sperm InjectionProcedure or surgery
Selection of sperm at 400x for sperm injection
Intra-cytoplasmic Morphologically-selected Sperm InjectionProcedure or surgery
Selection of sperm at 6000x for sperm injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI) Receives: Procedure: Intra-cytoplasmic Morphologically-selected Sperm Injection |
| Control | Active comparator | Intracytoplasmic sperm injection (ICSI) Receives: Procedure: Intra-cytoplasmic Sperm Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Four to six weeks after embryo transfer
Secondary outcomes (2)
Number of embryos obtained
Total number of embryos obtained
Measured: Two days after egg retrieval
Percentage of cycles with embryo transfer
Number of cycles reaching embryo transfer per cycle initiated
Measured: Two days after egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2018
- Study completion27 Feb 2019
Why it stopped: DIfficulties with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Infertilidad y Reproducción Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karinna Lattes, MD, Principal investigator, Centro de Infertilidad y Reproducción Humana (CIRH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358733
- Sponsor's protocol ID
- CIRH-BROIMSI-2014
- Other IDs
- 2014-003928-50, 2014
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2015
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02358733
- Acronym / sponsor ID
- CIRH-BROIMSI-2014
- Conditions
- Female Infertility
- Keywords
- POR, IMSI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DIfficulties with recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centro de Infertilidad y Reproducción HumanaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Intra-cytoplasmic Morphologically-selected Sperm InjectionIntra-cytoplasmic Morphologically-selected Sperm Injection (IMSI) |
| Control | Active comparator | Procedure: Intra-cytoplasmic Sperm InjectionIntracytoplasmic sperm injection (ICSI) |
Who may qualify
- Ages
- 37 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- poor ovarian response
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-cytoplasmic Sperm InjectionSelection of sperm at 400x for sperm injection | Procedure or surgery | Control |
| Intra-cytoplasmic Morphologically-selected Sperm InjectionSelection of sperm at 6000x for sperm injection | Procedure or surgery | Treatment |
Primary outcome
Clinical pregnancy rate
Time frame: 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
2 secondary outcomes
Number of embryos obtained
Time frame: Two days after egg retrieval
Percentage of cycles with embryo transfer
Time frame: Two days after egg retrieval
Results and safety
The study was stopped early (reason given: DIfficulties with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
Related trials for Female Infertility
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karinna Lattes, MD principal investigator
Centro de Infertilidad y Reproducción Humana (CIRH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-cytoplasmic Sperm Injection and Intra-cytoplasmic Morphologically-selected Sperm Injection in people with Female Infertility, run by Centro de Infertilidad y Reproducción Humana at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: DIfficulties with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: Four to six weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.