NCT06670586

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Maria Dolores Cuquerella Fernandez-Vazquez · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• In Vitro Fertilization
• Infertility Assisted Reproductive Technology

Interventions

Type	Name	Description
PROCEDURE	conventional in vitro fertilization	Fertilization via conventional In Vitro Fertilization
PROCEDURE	intracytoplasmic sperm injection (ICSI)	Fertilization via intracytoplasmic sperm injection

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-11-30
• Completion: 2025-03-01
• First posted: 2024-11-01
• Last updated: 2024-11-14

Locations

1 site across 1 country: Spain