Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time

Last updated: August 9, 2024
Sponsor: ART Fertility Clinics LLC
Overall Status: Completed

Phase

N/A

Condition

Infertility

Treatment

overnight exposure to sperm for IVF

2h exposure to sperm for IVF

Clinical Study ID

NCT04627545
2010-ABU-010-ND
  • Ages 18-43
  • Female
  • Accepts Healthy Volunteers

Study Summary

The current pilot study aims to evaluate the fertilization rates between sibling oocytes subjected to short incubation (2h) versus overnight incubation (16-20h). As secondary objectives, the abnormal fertilization, embryo development, blastocyst biopsy and euploid rates will be analyzed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sperm parameters

  • Sperm concentration before capacitation: >15 million per ml (WHO) Totalmotility (PR+NP %): >40 (WHO) Progressive motility (PR %):>32 (WHO)

  • Sperm concentration after capacitation: >0.6 million per ml (not WHO defined)Progressive motility (PR %):>65 (WHO)

  • ≥6 COCs assigned to IVF

  • BMI ≤35 kg/m2

  • Female age 18 to ≤ 43 years

  • All ovarian stimulation protocols

  • Fresh ejaculates

  • Abstinence duration 2-5 days

  • Presence or absence of sperm morphology data: as we do not have a diagnostic spermanalysis for all patients, the presence or absence of >4% normal morphology (WHO)will not be taken into account, even with known low (<4%) normal morphology

  • Couples requesting Preimplantation Genetic Testing for Aneuploidies

  • Arab population

Exclusion

Exclusion Criteria:

  • If the volume to be added after IVF is insufficient to perform IVF on all neededoocytes

  • Presence of >1 million per ml round cells in the ejaculate

  • If a couple's previous cycle was included in the study

  • Previous history of fertilization failure or <50% fertilisation

  • Globozoospermia

  • PCO according to the Rotterdam criteria

  • Progesterone >1.5 ng/ml on the day of trigger

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: overnight exposure to sperm for IVF
Phase:
Study Start date:
November 03, 2020
Estimated Completion Date:
July 30, 2023

Study Description

All patients for whom at least 6 cumulus oocytes complexes (COCs) are assigned to IVF, with normal sperm parameters, are eligible for the study. An electronically generated randomization list will allocate the first half of the oocytes to one arm and the other half of the oocytes to the second arm. In case an odd number of oocytes will be inseminated, one extra oocyte will be allocated to the first arm. In this prospective observational pilot study, the fertilization potential of 40 patients will be evaluated.

Connect with a study center

  • ART Fertility Clinics

    Abu Dhabi,
    United Arab Emirates

    Site Not Available

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