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Reduction of patient discomfort, risks and costs, but not pregnancies, by a mild strategy for in-vitro fertilization

Reduction of patient discomfort, risks and costs, but not pregnancies, by a mild strategy for in-vitro fertilization
Reduction of patient discomfort, risks and costs, but not pregnancies, by a mild strategy for in-vitro fertilization
Objective:

To compare a so-called mild in-vitro fertilisation (IVF) treatment strategy with the standard IVF treatment on the following aspects: the chance of a pregnancy resulting in full-term live birth within 1 year, patient discomfort, multiple pregnancies, and costs.

Design: Randomised, open-label, prospective trial (www.controlledtrials.com, number ISRCTN35766970).

Method: 404 patients were assigned to undergo either a mild treatment, consisting of ovarian stimulation with a gonadotrophin releasing hormone (GnRH) antagonist combined with single embryo transfer, or the standard treatment consisting of prolonged stimulation with a GnRH agonist combined with the transfer of two embryos. The primary outcome measures were: (1) the percentage of cumulative pregnancies within one year after randomisation leading to full-term live birth; (2) total costs per couple and child up to 6 weeks after expected delivery; and (3) overall patient discomfort. Analysis was done according to the intention-to-treat principle and was intended to show that the mild treatment was not inferior to the standard treatment; the non-inferiority threshold was -12.5%.

Results:

The proportion of cumulative pregnancies resulting in full-term live birth after 1 year was 43.4% in the mild and 44.7% in the standard treatment group. The lower limit of the one-sided 95% confidence interval was equal to -9.8%. The respective proportion of couples with multiple pregnancies was 0.5% versus 13.1% (p < 0.0001), and the average total costs were Euro 8,333.- versus Euro 10,745.- (difference: Euro 2,412.-, 95% CI: 703-4,131). There were no statistically significant differences between the groups with regard to anxiety, depression, physical discomfort, and sleep quality.

Conclusion: After 1 year of treatment, the cumulative percentage of pregnancies leading to full-term live birth and the total patient discomfort were the same for the mild treatment (average 2.3 IVF-cycles) and the standard treatment (average 1.7 IVF-cycles). The mild treatment significantly reduced the number of multiple pregnancies and the overall costs.
0028-2162
809-816
Heijnen, E.M.
e95569e1-8b98-499b-b7cb-22a5345a0847
Eijkemans, M.J.
7a7d87b5-76e0-48b3-85f1-bc0f56942134
de Klerk, C.
88ccdcb8-6b69-4c43-9d76-b89aef5ff3b4
Polinder, S.
e6f6af14-0952-43c3-a331-056fd2f06d84
Beckers, N.G.
a7e08353-20fd-41b1-9321-3a43aa248031
Klinkert, E.R.
c75b8605-35cc-429d-857a-0a769b73107f
Broekmans, F.J.
17ce14de-42f9-43cb-98be-194dc9430888
Passchier, J.
61f09c30-a51d-425d-818a-04a50caada6a
te Velde, E.R.
c81da583-bdbd-4f2c-b935-c236104184e0
Macklon, N.S.
7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e
Fauser, B.C.
a74bd2e3-1d5e-43c1-a6e8-c67c4973f484
Heijnen, E.M.
e95569e1-8b98-499b-b7cb-22a5345a0847
Eijkemans, M.J.
7a7d87b5-76e0-48b3-85f1-bc0f56942134
de Klerk, C.
88ccdcb8-6b69-4c43-9d76-b89aef5ff3b4
Polinder, S.
e6f6af14-0952-43c3-a331-056fd2f06d84
Beckers, N.G.
a7e08353-20fd-41b1-9321-3a43aa248031
Klinkert, E.R.
c75b8605-35cc-429d-857a-0a769b73107f
Broekmans, F.J.
17ce14de-42f9-43cb-98be-194dc9430888
Passchier, J.
61f09c30-a51d-425d-818a-04a50caada6a
te Velde, E.R.
c81da583-bdbd-4f2c-b935-c236104184e0
Macklon, N.S.
7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e
Fauser, B.C.
a74bd2e3-1d5e-43c1-a6e8-c67c4973f484

Heijnen, E.M., Eijkemans, M.J., de Klerk, C., Polinder, S., Beckers, N.G., Klinkert, E.R., Broekmans, F.J., Passchier, J., te Velde, E.R., Macklon, N.S. and Fauser, B.C. (2008) Reduction of patient discomfort, risks and costs, but not pregnancies, by a mild strategy for in-vitro fertilization. Nederlands Tijdschrift voor Geneeskunde, 152 (14), 809-816.

Record type: Article

Abstract

Objective:

To compare a so-called mild in-vitro fertilisation (IVF) treatment strategy with the standard IVF treatment on the following aspects: the chance of a pregnancy resulting in full-term live birth within 1 year, patient discomfort, multiple pregnancies, and costs.

Design: Randomised, open-label, prospective trial (www.controlledtrials.com, number ISRCTN35766970).

Method: 404 patients were assigned to undergo either a mild treatment, consisting of ovarian stimulation with a gonadotrophin releasing hormone (GnRH) antagonist combined with single embryo transfer, or the standard treatment consisting of prolonged stimulation with a GnRH agonist combined with the transfer of two embryos. The primary outcome measures were: (1) the percentage of cumulative pregnancies within one year after randomisation leading to full-term live birth; (2) total costs per couple and child up to 6 weeks after expected delivery; and (3) overall patient discomfort. Analysis was done according to the intention-to-treat principle and was intended to show that the mild treatment was not inferior to the standard treatment; the non-inferiority threshold was -12.5%.

Results:

The proportion of cumulative pregnancies resulting in full-term live birth after 1 year was 43.4% in the mild and 44.7% in the standard treatment group. The lower limit of the one-sided 95% confidence interval was equal to -9.8%. The respective proportion of couples with multiple pregnancies was 0.5% versus 13.1% (p < 0.0001), and the average total costs were Euro 8,333.- versus Euro 10,745.- (difference: Euro 2,412.-, 95% CI: 703-4,131). There were no statistically significant differences between the groups with regard to anxiety, depression, physical discomfort, and sleep quality.

Conclusion: After 1 year of treatment, the cumulative percentage of pregnancies leading to full-term live birth and the total patient discomfort were the same for the mild treatment (average 2.3 IVF-cycles) and the standard treatment (average 1.7 IVF-cycles). The mild treatment significantly reduced the number of multiple pregnancies and the overall costs.

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Published date: April 2008

Identifiers

Local EPrints ID: 150615
URI: http://eprints.soton.ac.uk/id/eprint/150615
ISSN: 0028-2162
PURE UUID: 37c186b2-55c8-4308-8e59-05a82d886e69

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Date deposited: 06 May 2010 08:54
Last modified: 08 Jan 2022 02:27

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Contributors

Author: E.M. Heijnen
Author: M.J. Eijkemans
Author: C. de Klerk
Author: S. Polinder
Author: N.G. Beckers
Author: E.R. Klinkert
Author: F.J. Broekmans
Author: J. Passchier
Author: E.R. te Velde
Author: N.S. Macklon
Author: B.C. Fauser

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