Infertility Assisted Reproductive Technology, In Vitro Fertilization
Conditions
Keywords
In Vitro Fertilization, ICSI, randomized controlled trial, sibling oocytes
Brief 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.
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.
Interventions
PROCEDUREconventional in vitro fertilization
Fertilization via conventional In Vitro Fertilization
Fertilization via intracytoplasmic sperm injection
Sponsors
Maria Dolores Cuquerella Fernandez-Vazquez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usable blastocyst rate | From oocyte retrieval to 6 days after | Percentage of oocytes that develop to blastocyst stage and are transferred of cryopreserved |
| Fertilization rate | From oocyte retrieval to 24 hours later | Percentage of oocytes that show normal fertilization |
| Blastocyst rate | From oocyte retrieval to 6 days after | Percentage of oocytes that develop to blastocyst stage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | From embryo transfer to 14 days later | Percentage of embryo transfers that has a positive beta-hCG 14 days post-transfer |
| Clinical pregnancy rate | From embryo transfer to 4 weeks later | Percentage of transfers that have a gestational sac observed 4 weeks post-transfer |
| Live birth delivery rate | From embryo transfer to 40 weeks later | Percentage of transfers that end with the delivery of at least one live baby |
Countries
Spain
Outcome results
None listed