中华妇产科杂志
中華婦產科雜誌
중화부산과잡지
CHINESE JOUNAL OF OBSTETRICS AND GYNECOLOGY
2013年
11期
838-842
,共5页
卵泡刺激素%受精,体外%胚胎移植%排卵诱导%妊娠结局
卵泡刺激素%受精,體外%胚胎移植%排卵誘導%妊娠結跼
란포자격소%수정,체외%배태이식%배란유도%임신결국
Follicle stimulating hormone%Fertilization in vitro%Embryo transfer%Ovulation induction%Pregnancy outcome
目的 探讨国产尿源性高纯度FSH(HP-FSH,其他名称:丽申宝)在控制性促排卵(COS)中对体外受精(IVF)-胚胎移植(ET)结局的影响.方法 采用回顾性分析方法,按2∶1病历随机抽样方法,抽取全国14个生殖中心2010年9月1日至2011年3月31日间具有IVF和(或)卵母细胞胞质内单精子注射(ICSI)指征并首次接受IVF或ICSI助孕治疗的不孕症患者3178例,其不孕原因包括了除排卵障碍性不孕及子宫因素不孕的所有不孕因素.COS方案为促性腺激素释放激素激动剂(GnRH-a)黄体期长方案,使用长效或短效曲普瑞林降调节,当达到降调节标准(按各生殖中心降调标准)后,开始用促性腺激素(Gn)促排卵,以FSH启动日所用FSH种类的不同分为两组:HP-FSH组1932例和基因重组FSH(rFSH,其他名称:果纳芬)组1246例,根据患者个体情况,FSH启动剂量为150 ～ 300 U,并可根据卵泡发育情况调整剂量,当卵泡发育至直径14 ～ 16 mm时,应用人绝经期促性腺激素(hMC) 150 U.当有3个优势卵泡直径达18 mm时,给予肌内注射尿hCG 5000 ～ 10 000 U或基因重组hCG 250μg,注射后34 ～36 h阴道超声下取卵,按各中心常规进行IVF或ICSI.72 h后进行ET,每例患者移植胚胎数≤3个.主要观察指标为周期出生率,次要观察指标包括临床妊娠率、流产率、着床率以及COS和IVF结局等.结果 (1)两组患者基本特征:患者年龄HP-FSH组为(32±4)岁,rFSH组为(30±4)岁;不孕年限HP-FSH组为(5±4)年,rFSH组为(5±3)年;基础窦卵泡计数(AFC) HP-FSH组为(11±5)个,rFSH组为(13±7)个,上述各项基本特征两组间比较,差异均有统计学意义(P＜0.01).(2) COS情况:COS方案中Gn用量HP-FSH组为(2348±1011)U,rFSH组为(2022±659)U;获卵数HP-FSH组为(13±6)个,rFSH组为(14±7)个;周期冷冻率HP-FSH组为66.30％(1281/1932),rFSH组为74.88％(933/1246);上述各项指标两组比较,差异也均有统计学意义(P＜0.01).但HP-FSH组和rFSH组着床率[分别为30.49％(1111/3644)、32.45％ (737/2271)]、周期临床妊娠率[分别为41.61％(804/1932)、41.97％ (523/1246)]、周期出生率[分别为34.21％(661/1932)、34.19％(426/1246)]、ET周期临床妊娠率[分别为46.58％(804/1726)、48.47％(523/1079)]、ET周期出生率[分别为38.30％ (661/1726)、39.48％(426/1079)]、流产率[分别为13.6％(109/804)、16.4％ (86/523)]及中重度卵巢过度刺激综合征(OHSS)发生率[分别为5.80％(112/1932)、7.78％(97/1246)]比较,差异均无统计学意义(P＞0.05).(3)治疗费用:HP-FSH组辅助生殖治疗中Gn费用为(4005±1650)元,rFSH组为(6482±2095)元,两组比较,差异有统计学意义(P＜0.01).结论 在IVF和(或)ICSI中,使用国产HP-FSH进行COS具有与rFSH等同的临床妊娠率及出生率,而且价格便宜,是一种可供选择的Gn药物.
目的 探討國產尿源性高純度FSH(HP-FSH,其他名稱:麗申寶)在控製性促排卵(COS)中對體外受精(IVF)-胚胎移植(ET)結跼的影響.方法 採用迴顧性分析方法,按2∶1病歷隨機抽樣方法,抽取全國14箇生殖中心2010年9月1日至2011年3月31日間具有IVF和(或)卵母細胞胞質內單精子註射(ICSI)指徵併首次接受IVF或ICSI助孕治療的不孕癥患者3178例,其不孕原因包括瞭除排卵障礙性不孕及子宮因素不孕的所有不孕因素.COS方案為促性腺激素釋放激素激動劑(GnRH-a)黃體期長方案,使用長效或短效麯普瑞林降調節,噹達到降調節標準(按各生殖中心降調標準)後,開始用促性腺激素(Gn)促排卵,以FSH啟動日所用FSH種類的不同分為兩組:HP-FSH組1932例和基因重組FSH(rFSH,其他名稱:果納芬)組1246例,根據患者箇體情況,FSH啟動劑量為150 ～ 300 U,併可根據卵泡髮育情況調整劑量,噹卵泡髮育至直徑14 ～ 16 mm時,應用人絕經期促性腺激素(hMC) 150 U.噹有3箇優勢卵泡直徑達18 mm時,給予肌內註射尿hCG 5000 ～ 10 000 U或基因重組hCG 250μg,註射後34 ～36 h陰道超聲下取卵,按各中心常規進行IVF或ICSI.72 h後進行ET,每例患者移植胚胎數≤3箇.主要觀察指標為週期齣生率,次要觀察指標包括臨床妊娠率、流產率、著床率以及COS和IVF結跼等.結果 (1)兩組患者基本特徵:患者年齡HP-FSH組為(32±4)歲,rFSH組為(30±4)歲;不孕年限HP-FSH組為(5±4)年,rFSH組為(5±3)年;基礎竇卵泡計數(AFC) HP-FSH組為(11±5)箇,rFSH組為(13±7)箇,上述各項基本特徵兩組間比較,差異均有統計學意義(P＜0.01).(2) COS情況:COS方案中Gn用量HP-FSH組為(2348±1011)U,rFSH組為(2022±659)U;穫卵數HP-FSH組為(13±6)箇,rFSH組為(14±7)箇;週期冷凍率HP-FSH組為66.30％(1281/1932),rFSH組為74.88％(933/1246);上述各項指標兩組比較,差異也均有統計學意義(P＜0.01).但HP-FSH組和rFSH組著床率[分彆為30.49％(1111/3644)、32.45％ (737/2271)]、週期臨床妊娠率[分彆為41.61％(804/1932)、41.97％ (523/1246)]、週期齣生率[分彆為34.21％(661/1932)、34.19％(426/1246)]、ET週期臨床妊娠率[分彆為46.58％(804/1726)、48.47％(523/1079)]、ET週期齣生率[分彆為38.30％ (661/1726)、39.48％(426/1079)]、流產率[分彆為13.6％(109/804)、16.4％ (86/523)]及中重度卵巢過度刺激綜閤徵(OHSS)髮生率[分彆為5.80％(112/1932)、7.78％(97/1246)]比較,差異均無統計學意義(P＞0.05).(3)治療費用:HP-FSH組輔助生殖治療中Gn費用為(4005±1650)元,rFSH組為(6482±2095)元,兩組比較,差異有統計學意義(P＜0.01).結論 在IVF和(或)ICSI中,使用國產HP-FSH進行COS具有與rFSH等同的臨床妊娠率及齣生率,而且價格便宜,是一種可供選擇的Gn藥物.
목적 탐토국산뇨원성고순도FSH(HP-FSH,기타명칭:려신보)재공제성촉배란(COS)중대체외수정(IVF)-배태이식(ET)결국적영향.방법 채용회고성분석방법,안2∶1병력수궤추양방법,추취전국14개생식중심2010년9월1일지2011년3월31일간구유IVF화(혹)란모세포포질내단정자주사(ICSI)지정병수차접수IVF혹ICSI조잉치료적불잉증환자3178례,기불잉원인포괄료제배란장애성불잉급자궁인소불잉적소유불잉인소.COS방안위촉성선격소석방격소격동제(GnRH-a)황체기장방안,사용장효혹단효곡보서림강조절,당체도강조절표준(안각생식중심강조표준)후,개시용촉성선격소(Gn)촉배란,이FSH계동일소용FSH충류적불동분위량조:HP-FSH조1932례화기인중조FSH(rFSH,기타명칭:과납분)조1246례,근거환자개체정황,FSH계동제량위150 ～ 300 U,병가근거란포발육정황조정제량,당란포발육지직경14 ～ 16 mm시,응용인절경기촉성선격소(hMC) 150 U.당유3개우세란포직경체18 mm시,급여기내주사뇨hCG 5000 ～ 10 000 U혹기인중조hCG 250μg,주사후34 ～36 h음도초성하취란,안각중심상규진행IVF혹ICSI.72 h후진행ET,매례환자이식배태수≤3개.주요관찰지표위주기출생솔,차요관찰지표포괄림상임신솔、유산솔、착상솔이급COS화IVF결국등.결과 (1)량조환자기본특정:환자년령HP-FSH조위(32±4)세,rFSH조위(30±4)세;불잉년한HP-FSH조위(5±4)년,rFSH조위(5±3)년;기출두란포계수(AFC) HP-FSH조위(11±5)개,rFSH조위(13±7)개,상술각항기본특정량조간비교,차이균유통계학의의(P＜0.01).(2) COS정황:COS방안중Gn용량HP-FSH조위(2348±1011)U,rFSH조위(2022±659)U;획란수HP-FSH조위(13±6)개,rFSH조위(14±7)개;주기냉동솔HP-FSH조위66.30％(1281/1932),rFSH조위74.88％(933/1246);상술각항지표량조비교,차이야균유통계학의의(P＜0.01).단HP-FSH조화rFSH조착상솔[분별위30.49％(1111/3644)、32.45％ (737/2271)]、주기림상임신솔[분별위41.61％(804/1932)、41.97％ (523/1246)]、주기출생솔[분별위34.21％(661/1932)、34.19％(426/1246)]、ET주기림상임신솔[분별위46.58％(804/1726)、48.47％(523/1079)]、ET주기출생솔[분별위38.30％ (661/1726)、39.48％(426/1079)]、유산솔[분별위13.6％(109/804)、16.4％ (86/523)]급중중도란소과도자격종합정(OHSS)발생솔[분별위5.80％(112/1932)、7.78％(97/1246)]비교,차이균무통계학의의(P＞0.05).(3)치료비용:HP-FSH조보조생식치료중Gn비용위(4005±1650)원,rFSH조위(6482±2095)원,량조비교,차이유통계학의의(P＜0.01).결론 재IVF화(혹)ICSI중,사용국산HP-FSH진행COS구유여rFSH등동적림상임신솔급출생솔,이차개격편의,시일충가공선택적Gn약물.
Objective To investigate the effect of domestic urine-derived high-purity follicle-stimulating hormone (HP-FSH,Lishenbao) on the outcome of in vitro fertilization(IVF) embryo transfer (ET) in controlled ovarian stimulation (COS).Methods From 1 September 2010 to 31 March 2011,total of 3178 infertility patients from 14 Reproductive Center with IVF or intracytoplasmic sperm injection (ICSI) indications who accepted first IVF or ICSI cycle were studied retrospectively.Their causes of infertility include all infertility factors except ovulatory dysfunction infertility and uterine factor infertility.The only long luteal phase gonadotropin-releasing hormone agonist (GnRH-a) protocol was included.Patients were divided into 2 groups according to the type of follicle-stimulating hormone (FSH) agents used:1932 cases in HP-FSH group and 1246 cases in recombinant FSH (rFSH)group.Patients in both groups were combined with human menopausal gonadotropin (hMG) at doses of 150 U when follicle with diameter reached to 14-16 mm.When 3 dominate follicle with diameter reached 18 mm,hCG at dose of 5000 to 10 000 U orrecombinant hCG at dose of 250 μg was administered by intramuscular injection.After 34 to 36 hours,oocytes were obtained guided by ultrasound,then IVF-ET were underwent in their Reproductive Center.The primary endpoint was comparison of live birth rate between the two groups.The secondary endpoints were comparisons of clinical pregnancy rate,miscarriage rate,and implantation rate,as well as COS and IVF outcome between the two groups.Results (1) There were significantly differences in baseline characteristics of the patients between two groups.The mean age was elder(32 ±4 versus 30 ±4,P ＜0.01),the infertility duration was longer(5 ±4 versus 5 ± 3,P ＜ 0.01),and antral follicle count (AFC) was less (11 ± 5 versus 13 ± 7,P ＜ 0.01)in patients of HP-FSH group compared with those in patients of rFSH group.(2) As c ompared with rFSH,the total doses of gonadotropin needed was (2348 ± 1011) U in HP-FSH group versus (2022 ± 659) U in rFSH group,the number of oocytes 13 ± 6 in HP-FSH group aud 14 ±7 in rFSH group,the rate of embryo frozen cycle of 66.30％ (1281/1932) in HP-FSH group and 74.88％(933/1246) in rFSH group,which all reached statistical difference (P ＜0.01).However,there were no significant different implantation rate [30.49％ (1111/3644) versus 32.45％ (737/2271)] between two groups.The other clinical parameters did not show significant difference,including clinical pregnancy rate per started cycle [41.61％ (804/1932) versus 41.97％ (523/1246)],clinical pregnancy rate per ET cycle [46.58 ％ (804/1726) versus 48.47 ％ (523/1079)],live birth rate per started cycle [34.21％ (661 /1932) versus 34.19％ (426/1246)],live birth rate per ET cycle [38.30％ (661/1726) versus 39.48％(426/1079)],miscarriage rate [13.6％ (109/804) versus 16.4％ (86/523)],and moderate/severe ovarian hyperstimulation syndrome (OHSS) rate [5.80％ (112/1932) versus 7.78％ (97/1246)] (P ＞0.05).(3) Treatment cost:the cost of gonadotropins needed for the patients in HP-FSH group was lower than that in rFSH group(4005 ± 1650 versus 6482 ± 2095,P ＜ 0.01).Conclusion In IVF/ICSI treatment cycles,domestic HP-FSH has similar live birth rate and lower financial burden when compared with rFSH.
