Reply: Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects

doi:10.1093/hropen/hoae031

Comment

. 2024 May 11;2024(2):hoae031.

doi: 10.1093/hropen/hoae031. eCollection 2024.

Reply: Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects

Alexander Katalinic¹

Affiliations

PMID: 38784057
PMCID: PMC11112042
DOI: 10.1093/hropen/hoae031

Comment

Reply: Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects

Alexander Katalinic. Hum Reprod Open. 2024.

. 2024 May 11;2024(2):hoae031.

doi: 10.1093/hropen/hoae031. eCollection 2024.

Author

Alexander Katalinic¹

Affiliation

¹ Institute for Social Medicine and Epidemiology, University of Luebeck, Luebeck, Germany.

PMID: 38784057
PMCID: PMC11112042
DOI: 10.1093/hropen/hoae031

No abstract available

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Conflict of interest statement

A.K. received payment from Abbott for a talk at the IVF Worldwide congress on 22 September 2023.

Comment on

No additional risk of congenital anomalies after first-trimester dydrogesterone use: a systematic review and meta-analysis.
Katalinic A, Noftz MR, Garcia-Velasco JA, Shulman LP, van den Anker JN, Strauss Iii JF. Katalinic A, et al. Hum Reprod Open. 2024 Jan 23;2024(1):hoae004. doi: 10.1093/hropen/hoae004. eCollection 2024. Hum Reprod Open. 2024. PMID: 38344249 Free PMC article. Review.

Cited by

Why does the latest pharmacovigilance data not reflect clinical experience with dydrogesterone?
Pabuccu E, Aguilar A, de Azevedo Antunes R, Gefen E, Shulman LP. Pabuccu E, et al. Hum Reprod Open. 2025 May 26;2025(3):hoaf030. doi: 10.1093/hropen/hoaf030. eCollection 2025. Hum Reprod Open. 2025. PMID: 40497085 Free PMC article. No abstract available.

References

1. Faillie JL. Case-non-case studies: principle, methods, bias and interpretation. Therapie 2019;74:225–232. - PubMed
1. Henry A, Santulli P, Bourdon M, Treluyer JM, Chou Chana L.. O-150 birth defects reporting and the use of oral dydrogesterone in assisted reproductive technology: a global pharmacovigilance study. Hum Reprod 2023;38:dead093.177.
1. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (Editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane [Internet]. 2023; www.training.cochrane.org/handbook (10 April 2024, date last accessed).
1. Katalinic A, Noftz MR, Garcia-Velasco JA, Shulman LP, van den Anker JN, Strauss III, JF.. No additional risk of congenital anomalies after first-trimester dydrogesterone use: a systematic review and meta-analysis. Hum Reprod Open 2024;2024:hoae004. - PMC - PubMed
1. Matsuda S, Aoki K, Kawamata T, Kimotsuki T, Kobayashi T, Kuriki H, Nakayama T, Okugawa S, Sugimura Y, Tomita M. et al. Bias in spontaneous reporting of adverse drug reactions in Japan. PLoS One 2015;10:e0126413. - PMC - PubMed

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[1] Faillie JL. Case-non-case studies: principle, methods, bias and interpretation. Therapie 2019;74:225–232. - PubMed

[2] Faillie JL. Case-non-case studies: principle, methods, bias and interpretation. Therapie 2019;74:225–232. - PubMed

[3] Henry A, Santulli P, Bourdon M, Treluyer JM, Chou Chana L.. O-150 birth defects reporting and the use of oral dydrogesterone in assisted reproductive technology: a global pharmacovigilance study. Hum Reprod 2023;38:dead093.177.

[4] Henry A, Santulli P, Bourdon M, Treluyer JM, Chou Chana L.. O-150 birth defects reporting and the use of oral dydrogesterone in assisted reproductive technology: a global pharmacovigilance study. Hum Reprod 2023;38:dead093.177.

[5] Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (Editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane [Internet]. 2023; www.training.cochrane.org/handbook (10 April 2024, date last accessed).

[6] Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (Editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane [Internet]. 2023; www.training.cochrane.org/handbook (10 April 2024, date last accessed).

[7] Katalinic A, Noftz MR, Garcia-Velasco JA, Shulman LP, van den Anker JN, Strauss III, JF.. No additional risk of congenital anomalies after first-trimester dydrogesterone use: a systematic review and meta-analysis. Hum Reprod Open 2024;2024:hoae004. - PMC - PubMed

[8] Katalinic A, Noftz MR, Garcia-Velasco JA, Shulman LP, van den Anker JN, Strauss III, JF.. No additional risk of congenital anomalies after first-trimester dydrogesterone use: a systematic review and meta-analysis. Hum Reprod Open 2024;2024:hoae004. - PMC - PubMed

[9] Matsuda S, Aoki K, Kawamata T, Kimotsuki T, Kobayashi T, Kuriki H, Nakayama T, Okugawa S, Sugimura Y, Tomita M. et al. Bias in spontaneous reporting of adverse drug reactions in Japan. PLoS One 2015;10:e0126413. - PMC - PubMed

[10] Matsuda S, Aoki K, Kawamata T, Kimotsuki T, Kobayashi T, Kuriki H, Nakayama T, Okugawa S, Sugimura Y, Tomita M. et al. Bias in spontaneous reporting of adverse drug reactions in Japan. PLoS One 2015;10:e0126413. - PMC - PubMed

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Reply: Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects

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Reply: Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects

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