Assessment of Reproductive Outcomes in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus Intracytoplasmic Sperm Injection

Maria Dolores Cuquerella Fernandez-Vazquez

Status

Active, not recruiting

Conditions

Infertility Assisted Reproductive Technology

In Vitro Fertilization

Treatments

Procedure: conventional in vitro fertilization

Procedure: intracytoplasmic sperm injection (ICSI)

Study type

Interventional

Funder types

Other

Identifiers

NCT06670586

21/707-E

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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