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

ART Fertility Clinics LLC

Status: Completed

Conditions: Infertility

Treatments: Other: 2h exposure to sperm for IVF; Other: overnight exposure to sperm for IVF

Study type: Interventional

Funder types: Other

Identifiers

NCT04627545

2010-ABU-010-ND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Sperm parameters

  • Sperm concentration before capacitation: >15 million per ml (WHO) Total motility (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 sperm analysis 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

IVF: 2h exposure

Experimental group

Description:

Half of a patients' oocytes will be subjected to 2h exposure to sperm

Treatment:

Other: 2h exposure to sperm for IVF

IVF: overnight exposure

Active Comparator group

Description:

Half of a patients' oocytes will be subjected to overnight incubation with sperm (=usual practice).

Treatment:

Other: overnight exposure to sperm for IVF