Assessment of Reproductive Outcomes in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus Intracytoplasmic Sperm Injection
NCT ID: NCT06670586
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
128 participants
INTERVENTIONAL
2022-01-01
2025-03-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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conventional IVF (cIVF)
The oocytes of this arm will be fertilized using conventional In Vitro Fertilization (cIVF)
conventional in vitro fertilization
Fertilization via conventional In Vitro Fertilization
Intracytoplasmic Sperm Injection (ICSI)
The oocytes of this arm will be fertilized using Intracytoplasmic Sperm Injection (ICSI)
intracytoplasmic sperm injection (ICSI)
Fertilization via intracytoplasmic sperm injection
Interventions
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conventional in vitro fertilization
Fertilization via conventional In Vitro Fertilization
intracytoplasmic sperm injection (ICSI)
Fertilization via intracytoplasmic sperm injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Maria Dolores Cuquerella Fernandez-Vazquez
OTHER
Responsible Party
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Maria Dolores Cuquerella Fernandez-Vazquez
Principal Investigator
Locations
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Hospital Clinico San Carlos
Madrid, Madrid, Spain
Countries
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Other Identifiers
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21/707-E
Identifier Type: -
Identifier Source: org_study_id
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