Assisted Reproduction Safety and Risks

Reprotoxicity of intrauterine insemination and in vitro fertilization-embryo transfer disposables and products: a 4-year survey

Nijs M, Franssen K, Cox A, Wissmann D, Ruis H, Ombelet W

Published August 2009 Fertility and Sterility
DOI 10.1016/j.fertnstert.2008.07.011 PMID 18937937

RRM Academy Synopsis

Some IVF supplies, including gloves, reduced sperm motility in tests

A four-year survey at a Belgian fertility center found that 13 of 36 products tested reduced sperm motility below the lab's cutoff. The failures included eight brands of unpowdered surgical gloves. Researchers exposed normal donated semen to each product in 350 sperm survival tests.

Study at a glance, prospective survey: 13 of 36 products tested reduced sperm motility
Study at a glance, prospective survey: 13 of 36 products tested reduced sperm motility. Source: Nijs M et al., 2009, PMID 18937937.

Key Findings

  • Twenty-eight of the 350 tests identified 13 of 36 products as reprotoxic, meaning a sperm survival test index below 0.85 at 24 hours, 96 hours, or both.
  • Ten product types had an index of 0 in 16 tests, with no sperm motility at 24 hours: eight unpowdered glove brands, one ultrasound condom type, and one hysterometer type.
  • Four product types showed delayed reprotoxicity, with the index below 0.85 by 96 hours: needle tubing (0.2), a petri dish (0.16), a Pasteur pipette (0.56), and a petri dish cover (0.56).
  • A replacement hysterometer batch passed (1.10 at 24 hours, 0.90 at 96 hours), as did a redesigned ovum pickup needle (1.01 and 0.98).

Interpretation

The study is a prospective survey, a four-year quality control record from one Belgian center. The main outcome measure was the sperm survival test index; the paper reports no fertilization, embryo, or pregnancy results. Several products got a single test, so findings describe the brands and batches tested. The authors call the 0.85 cutoff arbitrary but generally used. They note a randomized study to confirm it would be ethically difficult.

RRM Context

IVF puts eggs, sperm, and embryos in contact with gloves, catheters, tubing, and culture dishes. The authors report that the products used on patients had no mouse embryo or endotoxin testing before release, apart from one needle type. Natural conception involves no laboratory supplies. Restorative reproductive medicine aims to find and treat the cause of infertility, with conception occurring in the body.

Abstract

Objective

To test consumables and other products used during oocyte collection, sperm preparation, IUI, embryo culture, and IVF-embryo transfer for their possible reprotoxic properties.

Design

A prospective 4-year survey of reprotoxicity testing of consumables and other products used in assisted reproductive technologies (ART).

Setting

Private infertility center in a university-affiliated teaching hospital.

Interventions

Thirty-six products of 72 different brands, including plastics, syringes, tubing, and surgical gloves were analyzed for their reprotoxicity in 350 human sperm survival tests (SpST).

Main Outcome Measures

The SpST index: percentage progressive motility of test sample/percentage progressive motility of control sample after 24 and 96 hours.

Results

Thirteen of 36 products were found to be reprotoxic: an SpST index <0.85 was noted 24 and 96 hours after exposure. These products included eight brands of unpowdered surgical gloves, two types of hysterometers and one type of tubing attached to the oocyte collection needle, one type of ovum pickup procedure needle, and one type of embryo transfer catheter. One type of condom used for ultrasound, one type of sterile Pasteur pipette and petri dish, as well as the cover of a specimen container, were reprotoxic.

Conclusions

The SpST is an inexpensive, easy, and reliable method to identify potential reprotoxic products and consumables used in ART procedures. These data underline the importance of the inclusion of the SpST in a continuous quality control (QC) program of ART outcome.

Topics

By this author

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Assisted Reproduction › Safety and Risks › Procedural Safety · Lifestyle and Environment › Environmental Exposures › Plastics and Microplastics · Research Methods › Preclinical Research › Laboratory Methods
Martine Nijs, Kim Franssen, Annemie Cox, Dolf Wissmann, Henk Ruis, Willem Ombelet
M Nijs, K Franssen, A Cox, D Wissmann, H Ruis, W Ombelet
PMID 18937937 18937937 DOI 10.1016/j.fertnstert.2008.07.011 10.1016/j.fertnstert.2008.07.011 Nijs et al. 2009, Nijs 2009