Assessment of Reproductive Outcomes in Non-Male Factor Infertility Patients: Conventional in Vitr… (NCT06670586) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of Reproductive Outcomes in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus Intracytoplasmic Sperm Injection
Spain128 participantsStarted 2022-01-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Usable blastocyst rate
Timeframe: From oocyte retrieval to 6 days after
2
Fertilization rate
Timeframe: From oocyte retrieval to 24 hours later