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Dydrogesterone Lotus 1 Publication Explainer
Scientific Literature
Griesinger G, Tournaye H, Macklon N, Petraglia F, Arck P, Blockeel C, van Amsterdam P, Pexman-Fieth C, Fauser BC. Dydrogesterone: pharmacological profile and mechanism of action as luteal phase support in assisted reproduction. Reprod Biomed Online. 2019 Feb;38(2):249-259.
Synopsis:
Dydrogesterone is a selective progesterone receptor agonist with high oral bioavailability. These key pharmacokinetic features allow for effective oral administration and may limit the risk of side-effects. Clinical studies have shown that oral dydrogesterone has a good benefit–risk profile, comparable to that of micronized vaginal progesterone, during luteal phase support.
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A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization
Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027.
Synopsis:
Oral dydrogesterone may replace MVP as the standard of care for luteal phase support in IVF, owing to the oral route being more patient-friendly than intravaginal administration, as well as it being a well-tolerated and efficacious treatment.
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Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial
Griesinger G, Blockeel C, Sukhikh GT, Patki A4, Dhorepatil B, Yang DZ, Chen ZJ, Kahler E, Pexman-Fieth C, Tournaye H. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2212-2221.
Synopsis:
Non-inferiority of oral dydrogesterone was demonstrated, with comparable pregnancy rates and live birth rates in the oral dydrogesterone and MVP gel groups. Oral dydrogesterone was well tolerated and had a similar safety profile to MVP gel.
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Clinical Summaries
Oral dydrogesterone for luteal phase support in fresh in vitro fertilization cycles: a new standard?
Griesinger G, Blockeel C, and Tournaye H
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Oral dydrogesterone treatment during early pregnancy to prevent recurrent pregnancy loss and its role in modulation of cytokine production: a double-blind, randomized, parallel, placebo-controlled trial
Kumar A, Begum N, Prasad S, Aggarwal S, and Sharma S
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A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization
Tournaye H, Sukhikh G, Kahler E, and Griesinger G
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Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial
Griesinger G, Blockeel C, Sukhikh GT, Patki A, Dhorepatil B, Yang DZ, Chen ZJ, Kahler E, Pexman-Fieth C, and Tournaye H
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Modulating fertility outcome in assisted reproductive technologies by the use of dydrogesterone
Patki A, and Pawar VC
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