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

NCT06670586 | Active Not Recruiting

• 1 other identifier: 21/707-E
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

In Vitro Fertilization; Infertility Assisted Reproductive Technology

Keywords

In Vitro Fertilization; ICSI; randomized controlled trial; sibling oocytes

Outcome Measures

Primary Outcomes (3)

• Usable blastocyst rate

  Percentage of oocytes that develop to blastocyst stage and are transferred of cryopreserved

  From oocyte retrieval to 6 days after

• 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

Secondary Outcomes (3)

• Pregnancy rate

  From embryo transfer to 14 days later

• Clinical pregnancy rate

  From embryo transfer to 4 weeks later

• Live birth delivery rate

  From embryo transfer to 40 weeks later

Study Arms (2)

conventional IVF (cIVF)

ACTIVE COMPARATOR

The oocytes of this arm will be fertilized using conventional In Vitro Fertilization (cIVF)

Procedure: conventional in vitro fertilization

Intracytoplasmic Sperm Injection (ICSI)

ACTIVE COMPARATOR

The oocytes of this arm will be fertilized using Intracytoplasmic Sperm Injection (ICSI)

Procedure: intracytoplasmic sperm injection (ICSI)

Interventions

conventional in vitro fertilization PROCEDURE

Fertilization via conventional In Vitro Fertilization

conventional IVF (cIVF)

intracytoplasmic sperm injection (ICSI) PROCEDURE

Fertilization via intracytoplasmic sperm injection

Intracytoplasmic Sperm Injection (ICSI)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Dolores Cuquerella Fernandez-Vazquez: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Interventions

Congresses as Topic; Fertilization in Vitro; Sperm Injections, Intracytoplasmic

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: January 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: March 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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.

Locations

ES (1)