GM-CSF (granulocyte macrophage colony-stimulating factor) supplementation in culture media for women undergoing assisted reproduction

Background: In vitro fertilisation (IVF) 'add-ons' are extra (non-essential) procedures, techniques or medicines, which usually claim to increase the chance of a successful IVF outcome. Use of IVF add-ons is believed to be widespread in many settings; however, information about add-on availability in Australasia is lacking. Aims:To understand which add-ons are advertised on Australasian IVF clinic websites, and what is the evidence for their benefit. Materials and Methods:A systematic assessment of website content was undertaken between December 2019-April 2020, capturing IVF add-ons advertised, including costs, claims of benefit, statements of risk or limitations, and evidence of effectiveness for improving live birth and pregnancy. A literature review assessed the strength and quality of evidence for each add-on.Results: Of the 40 included IVF clinics websites, 31 (78%) listed one or more IVF add-ons. A total of 21 different add-ons or add-on groups were identified, the most common being preimplantation genetic testing for aneuploidies (offered by 63% of clinics), time-lapse systems (33%) and assisted hatching (28%). In most cases (77%), descriptions of the IVF add-ons were accompanied by claims of benefit. Most claims (90%) were not quantified and very few referenced scientific publications to support the claims (9.8%). None of the add-ons were supported by high-quality

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“…Unclear if beneficial or no effect (low quality)40 Endometrial scratch (n = 4)…”

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confidence: 99%

IVF add‐ons in Australia and New Zealand: A systematic assessment of IVF clinic websites

Lensen

Chen²,

Goodman

et al. 2021

Aust NZ J Obst Gynaeco

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“…A recent Cochrane systematic review and meta-analysis showed that the addition of GM-CSF in the embryo culture medium did not increase LBR (OR 1.19; 95% CI 0.93 to 1.52; 2 RCTs; n = 1432; I 2 = 69%; low-quality evidence) and did not reduce miscarriage rate (OR 0.75; 95% CI 0.41 to 1.36; 2 RCTs; n = 1432; I 2 = 0%; low-quality evidence) compared to culture in conventional media without GM-CSF ( Armstrong etal. , 2020 ).…”

Section: Resultsmentioning

confidence: 99%

“…The Cochrane review analysed the data on multiple gestations (OR 1.24; 95% CI 0.73 to 2.10; 2 RCTs; n = 1432; I 2 = 35%; very low-quality evidence), preterm birth (OR 1.20; 95% CI 0.70 to 2.04; 2 RCTs; n = 1432; I 2 = 76%; very low-quality evidence), birth defects (OR 1.33; 95% CI 0.59 to 3.01; I 2 = 0%; 2 RCTs; n = 1432; low-quality evidence), and aneuploidy (OR 0.34; 95% CI 0.03 to 3.26; I 2 = 0%; 2 RCTs; n = 1432; low-quality evidence) and reported no increased incidence of any adverse events but with a large degree of uncertainty ( Armstrong etal. , 2020 ).…”

Section: Resultsmentioning

confidence: 99%

Good practice recommendations on add-ons in reproductive medicine

Lundin,

Bentzen,

Bozdag

et al. 2023

Human Reproduction

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STUDY QUESTION Which add-ons are safe and effective to be used in ART treatment? SUMMARY ANSWER Forty-two recommendations were formulated on the use of add-ons in the diagnosis of fertility problems, the IVF laboratory and clinical management of IVF treatment. WHAT IS KNOWN ALREADY The innovative nature of ART combined with the extremely high motivation of the patients has opened the door to the wide application of what has become known as ‘add-ons’ in reproductive medicine. These supplementary options are available to patients in addition to standard fertility procedures, typically incurring an additional cost. A diverse array of supplementary options is made available, encompassing tests, drugs, equipment, complementary or alternative therapies, laboratory procedures, and surgical interventions. These options share the common aim of stating to enhance pregnancy or live birth rates, mitigate the risk of miscarriage, or expedite the time to achieving pregnancy. STUDY DESIGN, SIZE, DURATION ESHRE aimed to develop clinically relevant and evidence-based recommendations focusing on the safety and efficacy of add-ons currently used in fertility procedures in order to improve the quality of care for patients with infertility. PARTICIPANTS/MATERIALS, SETTING, METHODS ESHRE appointed a European multidisciplinary working group consisting of practising clinicians, embryologists, and researchers who have demonstrated leadership and expertise in the care and research of infertility. Patient representatives were included in the working group. To ensure that the guidelines are evidence-based, the literature identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, recommendations were based on the professional experience and consensus of the working group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 46 independent international reviewers. A total of 272 comments were received and incorporated where relevant. MAIN RESULTS AND THE ROLE OF CHANCE The multidisciplinary working group formulated 42 recommendations in three sections; diagnosis and diagnostic tests, laboratory tests and interventions, and clinical management. LIMITATIONS, REASONS FOR CAUTION Of the 42 recommendations, none could be based on high-quality evidence and only four could be based on moderate-quality evidence, implicating that 95% of the recommendations are supported only by low-quality randomized controlled trials, observational data, professional experience, or consensus of the development group. WIDER IMPLICATIONS OF THE FINDINGS These guidelines offer valuable direction for healthcare professionals who are responsible for the care of patients undergoing ART treatment for infertility. Their purpose is to promote safe and effective ART treatment, enabling patients to make informed decisions based on realistic expectations. The guidelines aim to ensure that patients are fully informed about the various treatment options available to them and the likelihood of any additional treatment or test to improve the chance of achieving a live birth. STUDY FUNDING/COMPETING INTEREST(S) All costs relating to the development process were covered from ESHRE funds. There was no external funding of the development process or manuscript production. K.L. reports speakers fees from Merck and was part of a research study by Vitrolife (unpaid). T.E. reports consulting fees from Gynemed, speakers fees from Gynemed and is part of the scientific advisory board of Hamilton Thorne. N.P.P. reports grants from Merck Serono, Ferring Pharmaceutical, Theramex, Gedeon Richter, Organon, Roche, IBSA and Besins Healthcare, speakers fees from Merck Serono, Ferring Pharmaceutical, Theramex, Gedeon Richter, Organon, Roche, IBSA and Besins Healthcare. S.R.H. declares being managing director of Fertility Europe, a not-for-profit organization receiving financial support from ESHRE. I.S. is a scientific advisor for and has stock options from Alife Health, is co-founder of IVFvision LTD (unpaid) and received speakers’ fee from the 2023 ART Young Leader Prestige workshop in China. A.P. reports grants from Gedeon Richter, Ferring Pharmaceuticals and Merck A/S, consulting fees from Preglem, Novo Nordisk, Ferring Pharmaceuticals, Gedeon Richter, Cryos and Merck A/S, speakers fees from Gedeon Richter, Ferring Pharmaceuticals, Merck A/S, Theramex and Organon, travel fees from Gedeon Richter. The other authors disclosed no conflicts of interest. DISCLAIMER This Good Practice Recommendations (GPRs) document represents the views of ESHRE, which are the result of consensus between the relevant ESHRE stakeholders and are based on the scientific evidence available at the time of preparation. ESHRE GPRs should be used for information and educational purposes. They should not be interpreted as setting a standard of care or bedeemedinclusive of all proper methods of care, or be exclusive of other methods of care reasonably directed to obtaining the same results.Theydo not replace the need for application of clinical judgement to each individual presentation, or variations based on locality and facility type. Furthermore, ESHRE GPRs do not constitute or imply the endorsement, or favouring, of any of the included technologies by ESHRE.

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“…However, the implantation rates and pregnancy rates were different among investigated studies. According to a Cochrane meta-analysis, there was no evidence that GM-CSF supplemented culture media had any superiority compared to standard media in terms of clinical outcomes ( 32 ). Furthermore, only one large, randomized, controlled trial ended with positive results in LBRs between the study and control groups ( 26 ).…”

Section: Discussionmentioning

confidence: 99%

The impact of using culture media containing granulocyte-macrophage colony-stimulating factor on live birth rates in patients with a history of embryonic developmental arrest in previous in vitro fertilization cycles

Sipahi¹,

Mümüşoğlu²,

Akçay³

et al. 2021

J Turkish German Gynecol Assoc

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Objective: To investigate the effect of using culture media containing granulocyte-macrophage colony-stimulating factor (GM-CSF) on embryological data and reproductive outcomes in patients with early embryonic developmental arrest. Material and Methods: Retrospective case-control study. A total of 39 patients, whose embryos were incubated with culture media containing GM-CSF due to embryonic developmental arrest in two previous in vitro fertilization (IVF) cycles in-between January 2016 and November 2017 at Hacettepe University IVF Center, were enrolled. Control group was generated among patients with first IVF attempts due to tubal factor in the same time period. All embryos in the control group were incubated with single step culture medium (without GM-CSF). For the control group selection, matching was done 1:2 ratio considering female age, body mass index, number of M-II oocyte retrieved, and number of embryo transferred (n=80). Results: Demographic features and embryological data were comparable between two groups. Number of fertilized oocytes (2-pronuclear) was 3.7±2.0 in GM-CSF group and 3.9±2.5 in the control (p=0.576). Overall, number of embryos transferred (1.3±0.5 vs 1.3±0.5, respectively) and blastocyst transfer rate (67.6% vs 59.2%, respectively; p=0.401) were similar. For the reproductive outcomes, implantation rate (32.3% vs 33.1%, respectively; p=0.937), clinical pregnancy rate (33.3% vs 32.5%, respectively; p=0.770), and live birth rate (25.2% vs 26.2%, respectively; p=0.943) were similar. Conclusion: Using GM-CSF-containing culture media in patients with two previous failed IVF attempts due to embryonic developmental arrest might rectify embryological data and reproductive outcomes. To make solid conclusion further randomized controlled trials are warranted.

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GM-CSF (granulocyte macrophage colony-stimulating factor) supplementation in culture media for women undergoing assisted reproduction

Abstract: GM-CSF (granulocyte macrophage colony-stimulating factor) supplementation in culture media for women undergoing assisted reproduction.

Cited by 6 publications

References 50 publications

IVF add‐ons in Australia and New Zealand: A systematic assessment of IVF clinic websites

IVF add‐ons in Australia and New Zealand: A systematic assessment of IVF clinic websites

Good practice recommendations on add-ons in reproductive medicine

The impact of using culture media containing granulocyte-macrophage colony-stimulating factor on live birth rates in patients with a history of embryonic developmental arrest in previous in vitro fertilization cycles

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