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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: In Vitro Fertilization; Infertility Assisted Reproductive Technology
• Intervention / Treatment: Procedure: conventional in vitro fertilization; Procedure: intracytoplasmic sperm injection (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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional IVF (cIVF); The oocytes of this arm will be fertilized using conventional In Vitro Fertilization (cIVF)	Procedure: conventional in vitro fertilization; Fertilization via conventional In Vitro Fertilization
Active Comparator: Intracytoplasmic Sperm Injection (ICSI); The oocytes of this arm will be fertilized using Intracytoplasmic Sperm Injection (ICSI)	Procedure: intracytoplasmic sperm injection (ICSI); Fertilization via intracytoplasmic sperm injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization rate	Percentage of oocytes that show normal fertilization	From oocyte retrieval to 24 hours later
Blastocyst rate	Percentage of oocytes that develop to blastocyst stage	From oocyte retrieval to 6 days after
Usable blastocyst rate	Percentage of oocytes that develop to blastocyst stage and are transferred of cryopreserved	From oocyte retrieval to 6 days after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	Percentage of embryo transfers that has a positive beta-hCG 14 days post-transfer	From embryo transfer to 14 days later
Clinical pregnancy rate	Percentage of transfers that have a gestational sac observed 4 weeks post-transfer	From embryo transfer to 4 weeks later
Live birth delivery rate	Percentage of transfers that end with the delivery of at least one live baby	From embryo transfer to 40 weeks later

Collaborators and Investigators

• Sponsor: Maria Dolores Cuquerella Fernandez-Vazquez

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; In Vitro Fertilization; ICSI; sibling oocytes
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 21/707-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Who will be able to access the IPD: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

For what type of analysis: For individual participant data meta-analysis. How they will be able to access: Proposals should be directed to mariadolores.cuquerella@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No