Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial.
Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial.
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促性腺激素释放激素拮抗剂用于子宫内膜异位症患者(怀孕)的体外受精前治疗：一项前瞻性、双盲、安慰剂对照试验的研究方案。
DOI：
10.1136/bmjopen-2021-052043
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发表时间：
2022-06-17
期刊：
影响因子：
2.9
通讯作者：
Zhang, Heping
中科院分区：
文献类型：
--
作者：
Taylor, Hugh;Li, Howard J.;Carson, Sandra;Flores, Valerie;Pal, Lubna;Robbins, Jared;Santoro, Nanette F.;Segars, James H.;Seifer, David;Huang, Hao;Young, Steven;Zhang, Heping
不孕症是子宫内膜异位症的常见并发症。虽然体外受精-胚胎移植（IVF）成功地治疗了子宫内膜异位症相关的不孕症，但有证据表明，与其他不孕症病因相比，接受子宫内膜异位症相关不孕症生育治疗的女性的妊娠率可能会降低。在IVF之前使用促性腺激素释放激素（GnRH）激动剂已被建议提高成功率，但研究规模较小，很少报道活产率。最近批准的口服GnRH拮抗剂治疗子宫内膜异位症为正在接受IVF的子宫内膜异位症妇女提供了一种新的选择。目前尚无关于GnRH拮抗剂治疗糖尿病相关不孕症疗效的研究。本研究是一项多中心、前瞻性、随机、双盲、安慰剂对照试验，旨在研究GnRH拮抗剂预处理对接受IVF的子宫内膜异位症女性的疗效。共814例接受生育治疗的子宫内膜异位症患者将入组，并在接受IVF前以1：1的比例随机分配至两组：elagolix 200 mg每日两次或安慰剂治疗8周。然后，所有参与者将根据当地方案接受IVF治疗。主要结局是活产。次要结局包括卵母细胞数量、受精率、胚胎形态和着床率，以及已知的妊娠相关产科结局（妊娠高血压、产前出血、剖腹产和早产）的发生率。怀孕试验得到了约翰霍普金斯大学机构审查委员会的批准。研究结果将发表在同行评审的期刊上。NCT 04173169。
Infertility is a common complication of endometriosis. While in vitro fertilisation-embryo transfer (IVF) successfully treats endometriosis-associated infertility, there is some evidence that pregnancy rates may be diminished in women seeing fertility treatment for endometriosis-associated infertility compared with other etiologies of infertility. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility. This study is a multicentre, prospective, randomised, double-blind, placebo-controlled trial to study the efficacy of GnRH antagonist pretreatment for women with endometriosis who are undergoing IVF. A total of 814 patients with endometriosis undergoing fertility treatment will be enrolled and randomised 1:1 into two groups: elagolix 200 mg two times per day or placebo for 8 weeks, prior to undergoing IVF. All participants will then undergo IVF treatment per local protocols. The primary outcome is live birth. Secondary outcomes include oocyte number, fertilisation rate, embryo morphology and implantation rates, as well as rates of known endometriosis-related obstetrical outcomes (pregnancy-induced hypertension, antepartum haemorrhage, caesarean delivery and preterm birth). The PREGnant trial was approved by the Institutional Review Board at Johns Hopkins University. Results will be published in a peer-reviewed journal. NCT04173169.
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影响因子：
3.2
作者：
Macer ML;Taylor HS
通讯作者：
Taylor HS
影响因子：
6.7
作者：
Penzias, Alan;Bendikson, Kristin;Vernon, Michael
通讯作者：
Vernon, Michael
影响因子：
8.3
作者：
Muteshi, Charles M.;Ohuma, Eric O.;Becker, Christian M.
通讯作者：
Becker, Christian M.
影响因子：
6.1
作者：
Stephansson, Olof;Kieler, Helle;Falconer, Henrik
通讯作者：
Falconer, Henrik
子宫内膜异位症对辅助生殖技术结果的影响。
DOI：
10.1186/s12958-016-0217-2
发表时间：
2017-01-24
期刊：
Reproductive biology and endocrinology : RB&E
影响因子：
--
作者：
González-Comadran M;Schwarze JE;Zegers-Hochschild F;Souza MD;Carreras R;Checa MÁ
通讯作者：
Checa MÁ