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. 2021 Mar 18;2021(3):CD011424. doi: 10.1002/14651858.CD011424.pub3

Gibreel 2013.

Methods Randomised controlled trial, 2 groups, set in Mansoura University Hospital and in a private practice, Egypt
July 2009 to December 2010
Number of participants randomised: 105
Number of participants analysed: 105
Participants Inclusion criteria: women between 20 and 39 years of age; ≥ 1 year of infertility; regular menstruation with length of cycle between 22 and 34 days; ovulation confirmed by appropriately timed mid‐luteal progesterone; fertile semen variables (according to World Health Organization criteria 1999); bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography)
Exclusion criteria: not reported
Cause infertility: unexplained
Interventions
  • Intervention group: endometrial scratching; endometrial samples were obtained on Day 21 to 26 of the spontaneous menstrual cycle using a biopsy catheter

  • Control group: placebo procedure using uterine sound was conducted at the luteal phase on Day 21 to 26 of the spontaneous menstrual cycle. The sound was manipulated in the uterine cavity by a similar technique used for scratching with the pipelle


Both: all women received pain medicine and doxycycline after the procedure. Non‐hormonal contraception was advised for participants in both groups in that cycle.
Degree of endometrial injury: pipelle
Timing of endometrial injury: luteal phase (Day 21 to 26 of a spontaneous cycle; participants advised to use non‐hormonal contraception during the intervention cycle)
Study length: 6 cycles
Type of conception: intercourse at participants' convenience
Control group was administered a mock procedure, which was not intended to cause injury but is likely to have done so; therefore this may be considered an inappropriate control intervention (uterine sound)
Outcomes Reported in this paper:
  • Clinical pregnancy (all clinical pregnancies conceived during 6 months): clinical pregnancy confirmed by the presence of an intrauterine gestational sac on ultrasonography, with foetal heartbeats, 2 to 3 weeks following a positive pregnancy test

  • Multiple pregnancy rate

  • Ongoing pregnancy rates retrieved following author correspondence


Obtained from author correspondence:
  • Miscarriage rate (author correspondence revealed the miscarriage rate reported in the paper was loss between biochemical and clinical pregnancy, therefore not as per our definition. Miscarriages rate were supplied by author correspondence)

Notes Funding source: no external funding source other than salaries paid by Mansoura University (author correspondence)
Conflicts of interest: unknown
Trial registration: NCT01412606 (retrospectively registered)
Author correspondence was undertaken
This study was included in the original review (Lensen 2016). However, in an updated review, the study is moved to Studies awaiting classification.Badawy 2007 One of the trial authors (A. Badawy) has had several articles retracted due to concerns related to validity of the data (Badawy 2007; Badawy 2008a; Badawy 2008b), and is the topic of an editorial article in which systematic trial assessments focused on data integrity (Bordewijk 2020). As we were unable to verify the validity of the data from Gibreel 2013 after correspondence with the study author, we elected to place it under Studies awaiting classification