Clinical trial comparing recombinant human chorionic gonadotropin (hCG) to urinary hCG for induction of final follicular maturation in IVF-ET

체외수정시술을 위한 과배란 유도 시 유전자 재조합에 의하여 생산된 사람융모생식샘자극호르몬제의 임상적 효용성에 관한 연구

Lee, Hyang-Ah;Koo, Yun-Hee;Seo, Mi-Won;Kim, Sung-Hoon;Chae, Hee-Dong;Kang, Byung-Moon;Kim, Chung-Hoon
이향아;구윤희;서미원;김성훈;채희동;강병문;김정훈

  • Published : 20070400

Abstract

=목적: 보조 생식술을 위한 과배란 유도의 과정 중 최종 난포의 성숙 유도를 위하여, 임신한 여성의 뇨 중에서 추출된 사람융모생식샘자극호르몬제재의 투여는 필수적인 과정이다. 그러나 뇨 추출물 과정에서 생기는 정제 과정의 불확실성, 소변의 정도 관리의 어려움, 항원 항체 반응의 출현, 동일 단위당의 예측 불가능한 효능 등이 문제점으로 제기 되고 있다. 본 연구에서는 재조합법으로 생성된 사람융모생식샘자극호르몬제재의 최종 난포 성숙과 관련된 임상적 효용성을 알아보고자 하였다. 연구방법: 2005년 1월부터 9월까지 서울 아산병원 불임 클리닉에서 체외 수정술을 시행 받은 환자 84명을 대상으로 전향적으로 연구되었다. 난자 채취 36시간 전에 42명에게는 재조합 사람융모생식샘자극호르몬 250 μg투여 되었으며 대조군에는 요 추출 사람융모생식샘자극호르몬 10,000 IU가 투여되었다. 난자 채취일에 약물의 국소적 부작용이 조사되었고 3일 후에 배아 이식하였다. 또한 두 군의 채취된 난자의 수, 수정된 난자의 수와 질, 배아의 질, 임신률을 비교하였다.결과: 성선 자극 호르몬 투여 후 5일째의 혈중 사람융모생식샘 자극호르몬과 프로제스테론 농도는 재조합 사람융모생식샘자극호르몬을 투여받은 군에서 유의하게 높았다 (p<0.01, p<0.05). 그 외의 채취된 난자의 질과 개수, 배아의 질, 임신률은 차이를 보이지 않았다. 또한 동통, 가려움, 피하 출혈 등의 약물 투여 부위의 국소적 부작용은 재조합 사람융모생식샘자극호르몬을 투여받은 군에서 의미 있게 낮은 빈도를 나타냈다 (p<0.01, p<0.01 and p<0.05).

Keywords

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