In Vitro FertilizationNCT06670586
Assessment of Reproductive Outcomes in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus Intracytoplasmic Sperm Injection
A study testing conventional in vitro fertilization and intracytoplasmic sperm injection (ICSI) in people with In Vitro Fertilization and Infertility Assisted Reproductive Technology, run by Maria Dolores Cuquerella Fernandez-Vazquez at 1 site in Spain.
Trial summary
The aim of this clinical trial is to evaluate the efficiency of two fertilization techniques used in Assisted Reproduction: conventional In Vitro fertilization (cIVF) and Intracytoplasmic Sperm Injection (ICSI), in terms of in-vitro and clinical results, in non-male infertility patients, comparing them in sibling… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- In Vitro Fertilization, Infertility Assisted Reproductive Technology
- What is being tested?
- conventional in vitro fertilization and intracytoplasmic sperm injection (ICSI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 1 Mar 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with at least 6 fresh, own oocytes.
- Patients with culture to blastocyst stage for all the embryos.
- Non-male factor infertility patients: semen sample with a good progresive sperm count, appropriate for cIVF.
Who cannot join
- Patients not willing to sign the informed consent. Patients not understanding Spanish.
- Patients with severe endometriosis
- Patients with recurrent implantation failure: at least 2 miscarriages or at least 3 transfers with good-quality embryos without pregnancy.
- Patients presenting total fertilization failure or very poor results in any of the two techniques in previous cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Reproductive and Perinatal Outcomes According to the Fertilisation Technique in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus Intracytoplasmic Sperm Injection
The aim of this clinical trial is to evaluate the efficiency of two fertilization techniques used in Assisted Reproduction: conventional In Vitro fertilization (cIVF) and Intracytoplasmic Sperm Injection (ICSI), in terms of in-vitro and clinical results, in non-male infertility patients, comparing them in sibling oocytes.
The main questions it aims to answer are:
Read more
Does ICSI result in better fertilization rate, blastocyst rate or usable blastocyst rate? Does ICSI result in better pregnancy, clinical pregnancy and live birth rates?
Researchers will compare cIVF to ICSI in sibling oocytes to assess if a technique offers better results.
Participants undergoing an IVF/ICSI cycle will have their oocytes randomly divided in two groups: the oocytes from one group will be fertilized using cIVF and the oocytes from the other group using ICSI.
Read the detailed description
It is a prospective randomized study performed in the Reproduction Unit of Hospital Clinico San Carlos, in Madrid.
The study involves In Vitro Fertilization cycles with at least 6 oocytes retrieved and with normal semen parameters according to WHO.
The objective is to compare conventional In Vitro Fertilization (cIVF) and Intracytoplasmic Sperm Injection (ICSI) in sibling oocytes from the same cohort.
The oocytes obtained after the ovum pick up will be randomly divided in two groups and the fertilization technique (cIVF or ICSI) will be randomly assigned to each group.
Maturity stage, fertilization and embryo development to blastocyst will be individually recorded for every oocyte. Additionally, the destination of every embryo (transferred, cryopreserved or discarded) will be registered. This decision will be based just on embryo quality, irrespective of the fertilization technique.
MII rate, blastocyst rate and usable blastocyst (transferred or cryopreserved) rate will be calculated for each group.
Additionally, embryo transfers will be performed in the fresh cycle or in the associated thaw cycles using the cryopreserved embryos. In every transfer, the technique used to obtain the transferred embryo will be registered.
The results of the embryo transfers will be recorded as pregnancy (positive beta-hCG 14 days after transfer), clinical pregnancy (diagnosed by ultrasonographic visualization of a gestational sac 4 weeks after transfer, including ectopic pregnancy) and live birth delivery (deliveries with at least one live birth). Pregnancy rate, clinical pregnancy rate and live birth delivery rate will be calculated for each group.
- Being tested
- conventional in vitro fertilization, intracytoplasmic sperm injection (ICSI)
- Keywords
- In Vitro Fertilization, ICSI, randomized controlled trial, sibling oocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional in vitro fertilizationProcedure or surgery
Fertilization via conventional In Vitro Fertilization
intracytoplasmic sperm injection (ICSI)Procedure or surgery
Fertilization via intracytoplasmic sperm injection
| Study group | Role | What they receive |
|---|---|---|
| conventional IVF (cIVF) | Active comparator | The oocytes of this arm will be fertilized using conventional In Vitro Fertilization (cIVF) Receives: Procedure: conventional in vitro fertilization |
| Intracytoplasmic Sperm Injection (ICSI) | Active comparator | The oocytes of this arm will be fertilized using Intracytoplasmic Sperm Injection (ICSI) Receives: Procedure: intracytoplasmic sperm injection (ICSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usable blastocyst rate
Percentage of oocytes that develop to blastocyst stage and are transferred of cryopreserved
Measured: From oocyte retrieval to 6 days after
Fertilization rate
Percentage of oocytes that show normal fertilization
Measured: From oocyte retrieval to 24 hours later
Blastocyst rate
Percentage of oocytes that develop to blastocyst stage
Measured: From oocyte retrieval to 6 days after
Secondary outcomes (3)
Pregnancy rate
Percentage of embryo transfers that has a positive beta-hCG 14 days post-transfer
Measured: From embryo transfer to 14 days later
Clinical pregnancy rate
Percentage of transfers that have a gestational sac observed 4 weeks post-transfer
Measured: From embryo transfer to 4 weeks later
Live birth delivery rate
Percentage of transfers that end with the delivery of at least one live baby
Measured: From embryo transfer to 40 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Jan 2022
- Primary completion30 Nov 2023
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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
- Model description
- Oocytes obtained from every participant are divided in two groups and each group is randomly allocated to one of the two techniques that we want to analyze. So, there are not two groups of participants but two groups of oocytes from every participan
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Dolores Cuquerella Fernandez-Vazquez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Dolores Cuquerella Fernandez-Vazquez, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670586
- Sponsor's protocol ID
- 21/707-E
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reproductive and Perinatal Outcomes According to the Fertilisation Technique in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT06670586
- Acronym / sponsor ID
- 21/707-E
- Keywords
- In Vitro Fertilization, ICSI, randomized controlled trial, sibling oocytes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Maria Dolores Cuquerella Fernandez-VazquezUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 1 Nov 2024 (actual)
- 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.
The aim of this clinical trial is to evaluate the efficiency of two fertilization techniques used in Assisted Reproduction: conventional In Vitro fertilization (cIVF) and Intracytoplasmic Sperm Injection (ICSI), in terms of in-vitro and clinical results, in non-male infertility patients, comparing them in sibling oocytes.
The main questions it aims to answer are:
Does ICSI result in better fertilization rate, blastocyst rate or usable blastocyst rate? Does ICSI result in better pregnancy, clinical pregnancy and live birth rates?
Researchers will compare cIVF to ICSI in sibling oocytes to assess if a technique offers better results.
Participants undergoing an IVF/ICSI cycle will have their oocytes randomly divided in two groups: the oocytes from one group will be fertilized using cIVF and the oocytes from the other group using ICSI.
Detailed description
It is a prospective randomized study performed in the Reproduction Unit of Hospital Clinico San Carlos, in Madrid.
The study involves In Vitro Fertilization cycles with at least 6 oocytes retrieved and with normal semen parameters according to WHO.
The objective is to compare conventional In Vitro Fertilization (cIVF) and Intracytoplasmic Sperm Injection (ICSI) in sibling oocytes from the same cohort.
The oocytes obtained after the ovum pick up will be randomly divided in two groups and the fertilization technique (cIVF or ICSI) will be randomly assigned to each group.
Maturity stage, fertilization and embryo development to blastocyst will be individually recorded for every oocyte. Additionally, the destination of every embryo (transferred, cryopreserved or discarded) will be registered. This decision will be based just on embryo quality, irrespective of the fertilization technique.
MII rate, blastocyst rate and usable blastocyst (transferred or cryopreserved) rate will be calculated for each group.
Additionally, embryo transfers will be performed in the fresh cycle or in the associated thaw cycles using the cryopreserved embryos. In every transfer, the technique used to obtain the transferred embryo will be registered.
The results of the embryo transfers will be recorded as pregnancy (positive beta-hCG 14 days after transfer), clinical pregnancy (diagnosed by ultrasonographic visualization of a gestational sac 4 weeks after transfer, including ectopic pregnancy) and live birth delivery (deliveries with at least one live birth). Pregnancy rate, clinical pregnancy rate and live birth delivery rate will be calculated for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Oocytes obtained from every participant are divided in two groups and each group is randomly allocated to one of the two techniques that we want to analyze. So, there are not two groups of participants but two groups of oocytes from every participan
| Arm | Type | Receives |
|---|---|---|
| conventional IVF (cIVF) | Active comparator | Procedure: conventional in vitro fertilizationThe oocytes of this arm will be fertilized using conventional In Vitro Fertilization (cIVF) |
| Intracytoplasmic Sperm Injection (ICSI) | Active comparator | Procedure: intracytoplasmic sperm injection (ICSI)The oocytes of this arm will be fertilized using Intracytoplasmic Sperm Injection (ICSI) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with at least 6 fresh, own oocytes.
- Patients with culture to blastocyst stage for all the embryos.
- Non-male factor infertility patients: semen sample with a good progresive sperm count, appropriate for cIVF.
Key exclusion criteria (4 listed)
- Patients not willing to sign the informed consent. Patients not understanding Spanish.
- Patients with severe endometriosis
- Patients with recurrent implantation failure: at least 2 miscarriages or at least 3 transfers with good-quality embryos without pregnancy.
- Patients presenting total fertilization failure or very poor results in any of the two techniques in previous cycles
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 |
|---|---|---|
| conventional in vitro fertilizationFertilization via conventional In Vitro Fertilization | Procedure or surgery | conventional IVF (cIVF) |
| intracytoplasmic sperm injection (ICSI)Fertilization via intracytoplasmic sperm injection | Procedure or surgery | Intracytoplasmic Sperm Injection (ICSI) |
Primary outcome
Usable blastocyst rate
Time frame: From oocyte retrieval to 6 days after
Percentage of oocytes that develop to blastocyst stage and are transferred of cryopreserved
Fertilization rate
Time frame: From oocyte retrieval to 24 hours later
Percentage of oocytes that show normal fertilization
Blastocyst rate
Time frame: From oocyte retrieval to 6 days after
Percentage of oocytes that develop to blastocyst stage
3 secondary outcomes
Pregnancy rate
Time frame: From embryo transfer to 14 days later
Clinical pregnancy rate
Time frame: From embryo transfer to 4 weeks later
Live birth delivery rate
Time frame: From embryo transfer to 40 weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional in vitro fertilization and intracytoplasmic sperm injection (ICSI) in people with In Vitro Fertilization and Infertility Assisted Reproductive Technology, run by Maria Dolores Cuquerella Fernandez-Vazquez 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2024. 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?
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?
Usable blastocyst rate (time frame: From oocyte retrieval to 6 days after). The study lists 3 primary outcomes in all. 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 14 Nov 2024.