JP7184935B2 - 生殖補助医療を受けている女性における着床及び妊娠のための黄体期のオキシトシン受容体アンタゴニスト療法 - Google Patents
生殖補助医療を受けている女性における着床及び妊娠のための黄体期のオキシトシン受容体アンタゴニスト療法 Download PDFInfo
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Description
本出願は、2014年12月22日に出願された欧州特許出願第14199709.8号及び2015年3月10日に出願された米国特許出願第14/643307号の利益を主張し、その内容は参照によりその全体が本明細書に組み込まれる。
a)自然排卵周期のLH+6日目とLH+9日目の間、好ましくはLH+6日目とLH+8日目の間、最も好ましくはLH+7日目;
b)誘発排卵周期のhCG+6日目とhCG+9日目の間、好ましくはhCG+6日目とhCG+8日目の間;最も好ましくはhCG+7日目;
c)IVF周期において卵母細胞回収の後の日から始まる黄体期補助の4日目と7日目の間、好ましくは4日目と6日目の間、より好ましくは5日目若しくは6日目、最も好ましくは5日目(好ましくは、女性は卵巣刺激を受けている);又は
d)好ましくは凍結胚移植又は第三者IVFの調製における、黄体期補助の4日目から9日目の間、好ましくは5日目から7日目の間、より好ましくは5日目若しくは6日目(好ましくは、黄体補助は、子宮内膜を外因性エストロゲンで少なくとも6日間、プライミングした後に始める)
に対応する。
1.初期の胚盤胞、胞胚腔は胚の体積の半分以下である
2.胚の体積の半分であるか半分以上である胞胚腔を有する胚盤胞
3.胚を完全に満たしている胞胚腔を有する胚盤胞
4.初期の胚よりも大きな胞胚腔体積を有し、細くなった帯を有する拡張胚盤胞
5.帯からヘルニア化が始まった栄養外胚葉を有する孵化中胚盤胞
6.胚盤胞が完全に帯から脱離した孵化後胚盤胞
RはCH3又はC2H5であり;
部分Sは、
Mpa 3 メルカプトプロピオン酸残基
Ile イソロイシン残基
Asn アスパラギン残基
Abu α-アミノ酪酸残基;
Xは、D-芳香族α-アミノ酸であり、Yは脂肪族α-アミノ酸である。好ましいオキシトシンアンタゴニストを図1に列挙する。
IVF/ICSI患者における、移植日に皮下投与されたバルシバンの着床率及び妊娠率についての効果を評価する、無作為化、プラセボを対照とした、二重盲検、並列群、多国籍、多施設の試験
BASICは、無作為化、二重盲検、プラセボを対照とした、並列群、多国籍、多施設の試験であった。これは、卵割期胚移植日又は胚盤胞移植日に投与されたバルシバンの、IVF/ICSI患者の継続着床率における効果を評価するために設計された。患者は、長いGnRHアゴニスト又はGnRHアンタゴニストプロトコールにおいて制御された卵巣刺激を受け、最終的な卵胞成熟を引き起こすためのhCGを受け、卵母細胞回収を受けたものであり、回収後1日目に開始する膣内プロゲステロンによる補充により毎日黄体期補助を受け、回収後3日目又は5日目に移植する。患者は、移植日(回収後3日目又は回収後5日目)及び移植すべき胚/胚盤胞の数(1又は2個)に従って層別化して、バルシバン群又はプラセボ群のいずれかに1:1の比率で無作為化した。合計で255人のIVF/ICSI患者を試験において無作為化し、440個の胚/胚盤胞の寄与であった。
回収後3日目移植の19%及び回収後5日目移植の38%の全体の継続着床率によって示されるように、異なる受容期及び卵割期胚及び胚盤胞の着床可能性に及ぼす治療の影響は明らかであった。バルシバン群とプラセボ群の両方で同じパターンが観察された。
1 この文書に提示されているデータは、プロトコルごとの(per-protocol; PP)集団についてのものである。同様の結果が治療企図(intention-to-treat、ITT)集団についても観察された。例えば、ITT集団についての継続着床率は、バルシバンで26.2%、プラセボで27.9%であった。
2 オッズ比はロジスティック回帰モデルに基づいており、部位、不妊の主要な理由及び胚/胚盤胞の品質について解析を補正する。
Claims (9)
- 生殖補助医療の一部として胚移植を受けている女性対象において、継続着床率を増加させ、継続妊娠率を増加させ、臨床妊娠率を増加させ、及び/又は出産率を増加させることに使用するためのオキシトシン受容体アンタゴニストを含む医薬組成物であって、
女性が卵割期胚の移植を受けており、
前記アンタゴニストが胚移植の2又は3日後に放出され、
前記オキシトシン受容体アンタゴニストがバルシバン又はOBE001である、医薬組成物。 - 前記アンタゴニストが胚移植の2又は3日後に女性に投与される、請求項1に記載の医薬組成物。
- 前記卵割期胚が少なくとも6つの割球と20%以下のフラグメント率を有する、請求項1又は2に記載の医薬組成物。
- 前記卵割期胚が受精後2日目又は3日目の胚である、請求項3に記載の医薬組成物。
- 前記アンタゴニストがバルシバンである、請求項1から4のいずれか一項に記載の医薬組成物。
- バルシバンが皮下に提供される、請求項5に記載の医薬組成物。
- 30~80mgの間のバルシバンが投与される、請求項5又は6に記載の医薬組成物。
- 50mgのバルシバンが投与される、請求項7に記載の医薬組成物。
- 前記アンタゴニストがOBE001である、請求項1から4のいずれか一項に記載の医薬組成物。
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EP14199709.8A EP3037101B1 (en) | 2014-12-22 | 2014-12-22 | Oxytocin receptor antagonist therapy in the luteal phase for implantation and pregnancy in women undergoing assisted reproductive technologies |
EP14199709.8 | 2014-12-22 | ||
US14/643,307 | 2015-03-10 | ||
US14/643,307 US9579305B2 (en) | 2014-12-22 | 2015-03-10 | Oxytocin receptor antagonist therapy in the luteal phase for implantation and pregnancy in women undergoing assisted reproductive technologies |
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JP2021002022A Active JP7184935B2 (ja) | 2014-12-22 | 2021-01-08 | 生殖補助医療を受けている女性における着床及び妊娠のための黄体期のオキシトシン受容体アンタゴニスト療法 |
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US (4) | US9579305B2 (ja) |
EP (2) | EP3037101B1 (ja) |
JP (2) | JP6858130B2 (ja) |
KR (1) | KR20170135821A (ja) |
CN (2) | CN113940990A (ja) |
AU (1) | AU2015367900B2 (ja) |
BR (1) | BR112017013521A2 (ja) |
CA (1) | CA2971846A1 (ja) |
CL (1) | CL2017001640A1 (ja) |
EA (1) | EA201791361A1 (ja) |
ES (1) | ES2716862T3 (ja) |
IL (1) | IL253078B (ja) |
MX (1) | MX2017008455A (ja) |
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PH (1) | PH12017550030A1 (ja) |
PL (1) | PL3037101T3 (ja) |
SG (1) | SG11201705175RA (ja) |
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UA (1) | UA125492C2 (ja) |
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EP2845850A1 (en) | 2013-09-10 | 2015-03-11 | ObsEva S.A. | Pyrrolidine derivatives as oxytocin/vasopressin V1a receptors antagonists |
EP2886107A1 (en) | 2013-12-17 | 2015-06-24 | ObsEva S.A. | Oral formulations of pyrrolydine derivatives |
EP3164384B1 (en) | 2014-07-02 | 2019-12-04 | ObsEva S.A. | Crystalline (3z,5s)-5-(hydroxymethyl)-1-[(2'-methyl-1,1'-biphenyl-4-yl)carbonyl]pyrrolidin-3-one o-methyloxime useful in methods of treating conditions related to the ot-r activity |
EP3037101B1 (en) | 2014-12-22 | 2019-03-06 | Ferring B.V. | Oxytocin receptor antagonist therapy in the luteal phase for implantation and pregnancy in women undergoing assisted reproductive technologies |
KR20180099708A (ko) | 2016-01-04 | 2018-09-05 | 메르크 세로노 에스. 에이. | 하이드록시프로필티아졸리딘 카르복사미드 유도체의 알파-아미노 에스테르 및 이의 염 형태, 결정 다형체 |
ES2898778T3 (es) * | 2016-07-21 | 2022-03-08 | ObsEva SA | Pautas posológicas de antagonistas de oxitocina para promover la implantación de embriones y prevenir aborto espontáneo |
CA3149898A1 (en) | 2019-09-03 | 2021-03-11 | Ernest Loumaye | Oxytocin antagonist dosing regimens for promoting embryo implantation and preventing miscarriage |
CN115380122A (zh) | 2020-02-10 | 2022-11-22 | 奥布赛瓦股份公司 | 用于催产素受体拮抗剂疗法的生物标志物 |
CN114292907A (zh) * | 2020-12-15 | 2022-04-08 | 苏州亿康医学检验有限公司 | 用于反复植入失败的生物标志物和诊断与治疗方法 |
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JP2008540519A (ja) | 2005-05-10 | 2008-11-20 | フエリング・インターナシヨナル・センター・エス・アー | 生殖補助におけるオキシトシンのおよび/またはバソプレシンの拮抗薬の使用 |
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SE9604341D0 (sv) * | 1996-11-26 | 1996-11-26 | Ferring Bv | Hepta-peptide oxytocin analogue |
AUPP421298A0 (en) | 1998-06-19 | 1998-07-09 | Fertilitescentrum Ab | Method and medium for in vitro culture of human embryos |
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