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

NCT ID: NCT04627545

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2023-07-30

Brief 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.

Detailed 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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVF: 2h exposure

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

Group Type: EXPERIMENTAL

2h exposure to sperm for IVF

Intervention Type: OTHER

Oocytes will only be briefly (2h) exposed to progressive motile sperm for insemination

IVF: overnight exposure

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

Group Type: ACTIVE_COMPARATOR

overnight exposure to sperm for IVF

Intervention Type: OTHER

Oocytes will be exposed for a longer duration (overnight, 16-20h) to progressive motile sperm for insemination

Interventions

2h exposure to sperm for IVF

Oocytes will only be briefly (2h) exposed to progressive motile sperm for insemination

Intervention Type: OTHER

overnight exposure to sperm for IVF

Oocytes will be exposed for a longer duration (overnight, 16-20h) to progressive motile sperm for insemination

Intervention Type: OTHER

Other Intervention Names

short exposure; long exposure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ART Fertility Clinics LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neelke De Munck, PhD

Role: PRINCIPAL_INVESTIGATOR

ART Fertility Clinics

Locations

ART Fertility Clinics

Abu Dhabi, , United Arab Emirates

Countries

United Arab Emirates

Other Identifiers

2010-ABU-010-ND

Identifier Type: -

Identifier Source: org_study_id