NCT04627545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2.6 years

First QC Date

November 3, 2020

Last Update Submit

August 9, 2024

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Normal fertilization rate

    presence of two pronuclei per inseminated oocyte

    2 days

Secondary Outcomes (16)

  • Number of COCs assigned to each group

    2 days

  • Maturation rate

    2 days

  • Fertilization

    3 days

  • Total fertilization failure

    3 days

  • Embryo quality on day 3

    5 days

  • +11 more secondary outcomes

Study Arms (2)

IVF: 2h exposure

EXPERIMENTAL

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

Other: 2h exposure to sperm for IVF

IVF: overnight exposure

ACTIVE COMPARATOR

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

Other: overnight exposure to sperm for IVF

Interventions

2h exposure to sperm for IVFOTHER

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

Also known as: short exposure
IVF: 2h exposure
overnight exposure to sperm for IVFOTHER

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

Also known as: long exposure
IVF: overnight exposure

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients seeking fertility treatment
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ART Fertility Clinics

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

Infertility

Interventions

Threshold Limit Values

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Legislation as TopicSocial Control, FormalHealth Care Economics and OrganizationsOccupational ExposureEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public Health

Study Officials

  • Neelke De Munck, PhD

    ART Fertility Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Oocytes of one patient will be evenly and randomly distributed between two timings of exposure to sperm: 2h exposure versus overnight exposure (16-20h)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 13, 2020

Study Start

November 3, 2020

Primary Completion

June 1, 2023

Study Completion

July 30, 2023

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

The principal investigator will gather all data for the study and prepare the database for the statistician, who will be blinded for patient information.

Locations

AE(1)