A multicentre randomised controlled trial of induced endometrial scratch in women undergoing first time in vitro fertilisation (IVF)

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 1,048 人2016年5月31日

概览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29780028 protocol (added 17/05/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34050362/ (added 01/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34531221/ Qualitative results (added 21/09/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35129113/ (added 08/02/2022)

注册库

who.int

开始日期

2016年5月31日

结束日期

2020年9月30日

最后更新

4年前

研究类型

Interventional

性别

Female

发起方

•1\. Women aged \= 18 and \= 37 years of age at time of oocyte removal
•2\. Women expected to receive IVF with or without ICSI treatment using the antagonist or long protocol only
•3\. First time IVF with or without ICSI treatment
•4\. Ovulatory menstrual cycle. (Regular menstrual cycles with ovulatory levels of midluteal serum progesterone as defined by local laboratory protocols)
•5\. Normal uterine cavity assessed by transvaginal sonography at screening and no endometrial abnormalities such as , polyps, suspected intrauterine adhesions, uterine septa, submucosal fibroids or intramural fibroids exceeding 4 cm in diameter as assessed by the investigator that would require treatment to facilitate pregnancy
•6\. Local procedures have been followed to exclude relevant vaginal/uterine infections prior to starting treatment
•7\. Expected good ovarian reserve as assessed clinically and or laboratory (normal early follicular FSH (\<10\) \& normal AMH) and no history of previous radiotherapy or chemotherapy
•8\. Expected good responders in whom blastocyst transfer is expected (as assessed by clinical judgement)
•9\. Understands/willing to comply with the protocol
•10\. Willing to use a condom if randomised to Endometrial Scratch (ES) in the cycle where the ES procedure is performed

•1\. Single embryo transfer is not anticipated
•2\. Previous trauma/surgery to the endometrium e.g. resection of submucous fibroid, intrauterine adhesions
•3\. BMI\= 35 kg/m2
•4\. Known Grade 4 (severe) endometriosis
•5\. Women who have received cycle programming through the use of progestogens or the contraceptive pill in the lead up to their IVF treatment and for whom a wash out period of one month will not be possible
•6\. Currently participating in any other fertility study or a study involving medical/surgical intervention or previously randomised into this trial