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NCT Number: NCT06670586

Assessment of Reproductive Outcomes 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.

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Key information

Conditions

In Vitro Fertilization Infertility Assisted Reproductive Technology

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico San Carlos

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional in vitro fertilization

Procedure

Fertilization via conventional In Vitro Fertilization

Intracytoplasmic Sperm Injection (ICSI)

Procedure

Fertilization via intracytoplasmic sperm injection

Primary outcomes

  1. Usable blastocyst rate

    Time frame: From oocyte retrieval to 6 days after

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

  2. Fertilization rate

    Time frame: From oocyte retrieval to 24 hours later

    Percentage of oocytes that show normal fertilization

  3. Blastocyst rate

    Time frame: From oocyte retrieval to 6 days after

    Percentage of oocytes that develop to blastocyst stage

Secondary outcomes

  1. Pregnancy rate

    Time frame: From embryo transfer to 14 days later

    Percentage of embryo transfers that has a positive beta-hCG 14 days post-transfer

  2. Clinical pregnancy rate

    Time frame: From embryo transfer to 4 weeks later

    Percentage of transfers that have a gestational sac observed 4 weeks post-transfer

  3. Live birth delivery rate

    Time frame: From embryo transfer to 40 weeks later

    Percentage of transfers that end with the delivery of at least one live baby

Sponsors and collaborators

Lead sponsor

Maria Dolores Cuquerella Fernandez-Vazquez

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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