Endometrial scratch trial

Not Applicable

Completed

• Conditions: Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine; UKCRC code/ Disease: Reproduction/ Other obstetric conditions, not elsewhere classified; Pregnancy and Childbirth; Infertility

• Registration Number: ISRCTN23800982
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-31
• Study Completion: 2020-09-30
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1048

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified