SU Versus GD for Sperm Preparation in IUI

NCT04477356 | Completed DMC

• 1 other identifier: CS/BVMDPN/20/02
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

Brief Summary

Intrauterine insemination (IUI) is the first-line treatment for couples with unexplained and mild male factor infertility. The result of IUI depends on many factors including the sperm preparation techniques. Swim-up (SU) and Density Gradient (DG) are the two most commonly used techniques in sperm preparation for IUI. There is discussion about the effectiveness of these two techniques for IUI outcomes. The effectiveness of SU and DG methods on IUI success rate is not clearly understood and is controversial. This multicenter, randomized controlled trial will be conducted to determine which method (DG or SU) is better for IUI treatment.

Conditions

Infertility

Keywords

Swim-up (SU); Gradient density (GD); IUI

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 24 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. In the analysis for the primary endpoint, twin delivery will be considered.

  At 24 weeks of gestation

Secondary Outcomes (22)

• Total motile sperm count after sperm preparation

  At 5 minutes after sperm preparation for IUI

• Biochemical pregnancy rate

  At 14 days after insemination

• Clinical pregnancy rate

  At 7 weeks of gestation

• Ongoing pregnancy rate (OPR)

  At the 12 weeks of gestation

• Ectopic pregnancy rate

  At 5-7 weeks of gestation

Study Arms (2)

Swim-up technique (SU)

ACTIVE COMPARATOR

The SU method's principle is that the normal and highly motile sperm will move against the gravity and separate from the dead or abnormal sperms to swim up to the upper media culture layer.

Procedure: SU

Density gradient centrifugation technique (DG)

ACTIVE COMPARATOR

The DG method is based on the density in which mature and normal sperms are capable of passing through filtration layer to be isolated from dead or abnormal sperms in semen.

Procedure: DG

Interventions

SU PROCEDURE

Aliquot 1.2 ml Ferticult Flushing media (Fertipro, Belgium) into 14 ml tube and then gently add 1 ml semen sample to the bottom of the tube (in case of larger semen volume, use multiple 14 ml tubes). The tubes then will be hold at an angle of 45 degrees for 45-60 minutes at 37C. Collect 1 ml of supernatant and then wash with 2 ml Ferticult Flushing media by centrifugation at 1200 RPM for 10 minutes. Keeping 0.3 ml washed semen for IUI, sperm density counting. Prepared sperms will be transferred into uterus by soft catheter (Gynétics, Belgium).

Swim-up technique (SU)

DG PROCEDURE

Add 1.5 ml Sil-select 90% first and then 1.5 ml Sil-select 45% (Fertipro, Belgium) into centrifuge tube, then gently add 1 - 1.5 ml semen on the top of Sil-select layer and centrifuge at 1200 RPM for 15 minutes. Discard upper layer, collect 0.5 ml lower layer into new tube and then wash with 2 ml Ferticult Flushing media at 1200 RPM for 10 minutes. Discard upper layer then collect 0.3 ml lower layer for IUI, sperm density counting. Prepared sperms will be transferred into uterus by soft catheter (Gynétics, Belgium).

Density gradient centrifugation technique (DG)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing IUI
• Undergone ≤ 2 previous IUI cycles
• Progressive motility (PR) before sperm preparation: ≥ 32%
• Sperm concentration before sperm preparation: ≥ 5 million/ml
• Total progressive motility sperm count before sperm preparation: \> 5million
• Agree to participate in the study

You may not qualify if:

• Using frozen semen
• High viscosity semen

Sponsors & Collaborators

• Mỹ Đức Hospital: lead
• Mỹ Đức Phú Nhuận Hospital: collaborator

Study Sites (1)

Dang Q Vinh

Hochiminh City, Vietnam

Location

Related Publications (1)

• Duong TND, Dang VQ, Le TK, Vu ATL, Nguyen DL, Pham TD, Nguyen MT, Nguyen PTM, Vo TM, Nguyen CTH, Le PTB, Le AH, Tran CT, Mol BW, Vuong LN, Ho TM. Swim-up versus density gradients for sperm preparation in infertile couples undergoing intrauterine insemination: a randomized clinical trial. Hum Reprod. 2025 May 1;40(5):788-795. doi: 10.1093/humrep/deaf047.

  PMID: 40135621 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The prepared sperms will be proceeded to medical doctor who will carry the IUI and have no information about the semen preparation step.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 20, 2020
• Study Start: August 10, 2020
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 1, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)