Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination

NCT06144268 | Recruiting

• 1 other identifier: EC-2023-257
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This single centre interventional pilot randomized control study intends to compare two methods of sperm preparation for couples referred for Intra Uterine Insemination (IUI) procedure. Couples will be randomly allocated to one of the two sperm selection methods: Density Gradient Centrifugation (DGC, standard) or ZyMōt Multi (850µL) device (treatment) groups. The study will compare the live birth rate (number of live births per number of IUI procedures) between the treatment and standard groups.

Conditions

Infertility; Fertility Disorders

Keywords

Intra Uterine Insemination; Live birth; Microfluidic sperm selection

Outcome Measures

Primary Outcomes (1)

• Cumulative live birth rate after 3 consecutive IUIs

  Number of live births per number of inseminations

  9 months following IUI

Secondary Outcomes (2)

• Pregnancy rate

  14 days following IUI

• Miscarriages rate

  12 weeks following IUI

Study Arms (2)

Density Gradient Centrifugation (DGC)

ACTIVE COMPARATOR

During this procedure, raw semen sample is placed on 2 gradients: a lower phase (80%) and an upper phase (40%) followed by centrifugation. The composition of the gradients include a colloidal suspension of silica particles. At the end of centrifugation, each spermatozoa is situated at the gradient level that matches its density. The highly motile, morphologically normal, viable spermatozoa form a pellet at the bottom of the tube.

Other: Density Gradient Centrifugation

ZyMōt Multi (850µL)

EXPERIMENTAL

ZyMōt Multi (850µL) is a flow-free dual chambered single-use device. The first chamber contains a sample inlet and a fluid channel separated from the second collection chamber by an 8-μm microporous membrane. Channel dimension and membrane porosity are designed to optimize the sorting and collection of the most motile sperm. Sorting is accomplished by the passage of sperm through the micropores of the membrane. This procedure does not require any preliminary semen processing, all centrifugation steps being eliminated.

Device: ZyMōt Multi (850µL)

Interventions

ZyMōt Multi (850µL) DEVICE

An amount of 850 µl untreated semen sample will be loaded into the inlet chamber with a help of a sterile insulin-type syringe. A volume of 750 µl of Sage Quinn's AdvantageTM Medium with Hepes + 5% HSA-solution medium will be placed on top of the membrane (outlet chamber). After 30 min of incubation in a humidified incubator (37°C), 500 µl of medium, containing the selected spermatozoa, will be retrieved from the upper side of the membrane (retrieval chamber). An amount of 400 µl will be necessary for the IUI procedure.

Also known as: FERTILE Plus® device (KOEK EU GmbH, Biotechnology)

ZyMōt Multi (850µL)

Density Gradient Centrifugation OTHER

The gradient columns will be prepared by placing 1 ml 80% gradient media in a centrifuge tube and an additional 1 ml of 40% gradient layered on top. The raw semen sample will be placed on top of the gradient (1ml semen/gradient tube) and centrifuged at 300xg for 20 minutes. The sperm pellet will be collected and washed 2 times for 5 min at 800xg in Sage Quinn's AdvantageTM Medium with Hepes + 5% HSA-solution. The resulted pellet will be resuspended in the washing solution in a volume that will provide at least 1x106 forward motile spermatozoa in 400 µl, as this amount is necessary for IUI procedure.

Density Gradient Centrifugation (DGC)

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fresh autologous ejaculate
• Female age: \<37 at start of the first insemination
• st IUI ever here, maximum 3 consecutive IUIs during max 6 months
• BMI \<35
• All natural cycles, ovulation induction allowed
• Presence of 1 or 2 follicles at the last ultrasound
• Regular menses (26-35 days)
• \>1 million Total Progressive Motile Sperm Count (TPMC) after previous routine capacitation with DGC
• Presence of at least 1 potent tube after Hyfosy

You may not qualify if:

• Presence of intracavitary pathology at ultrasound
• Evidence of advance endometriosis (Grade 3 and 4)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel CRG

Brussels, 1090, Belgium

RECRUITING

Related Publications (1)

• Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.

  PMID: 31543253 RESULT

MeSH Terms

Conditions

Infertility

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultracentrifugation; Centrifugation; Investigative Techniques; Chemistry Techniques, Analytical

Study Officials

• Shari Mackens, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elsie Nulens

CONTACT

0032 2 4742676; elsie.nulens@uzbrussel.be

Ileana Mateizel, PhD

CONTACT

0032 24749119; ileana.mateizel@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: January 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 30, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)