The PIP studies
Research type
Research Study
Full title
Pipelle for Pregnancy (PIP) studies
IRAS ID
163415
Contact name
Sarah Lensen
Contact email
Sponsor organisation
Auckland District Health Board
Clinicaltrials.gov Identifier
ACTRN12614000626662, Australia and New Zealand Clinical Trials Registry (PIP-IVF); ACTRN12614000657628, Australia and New Zealand Clinical Trials Registry (PIP-PCOS); ACTRN12614000656639, Australia and New Zealand Clinical Trials Registry (PIP-UE)
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Research Summary:
Studies that have investigated the application of local endometrial biopsy (LEB) prior to IVF/ICSI have focussed on participants with recurrent implantation failure undergoing fresh embryo transfers. The procedure appears to be beneficial however the available evidence is associated with a high risk of bias and so the real benefit remains controversy. Further, its effectiveness in women undergoing frozen-thaw transfer or first time IVF has not been addressed.Additionally, there are only a handful of studies investigating the utility of LEB in couples undergoing natural conception; particularly when the indication of infertility is polycystic ovarian syndrome (PCOS) or is unexplained, in which case there is a possibility that endometrial receptivity is at least partly responsible for the subfertility.
The PIP studies will address these gaps by conducting three separate trials in women undergoing IVF/ICSI (PIP-IVF) and attempted natural conception (PIPUE and PIPPCOS).
Women will be randomised to receive either LEB or a similar mock/placebo procedure prior to intercourse in PIPUE and PIPPCOS.
Women in PIPIVF will be randomised to either the LEB procedure or no procedure. Please see protocol for rationale on this.The primary outcome of the studies is live birth. Secondary outcomes include: clinical pregnancy, miscarriage, multiple pregnancy and pain during procedure.
Lay Summary of Results:
We evaluated whether endometrial scratching, a type of optional extra that patients may be offered, can help women to conceive in three separate scenarios/trials.PIP-IVF recruited women having IVF
A total of 1364 women were recruited. We found the chance of having baby was the same in each group (26%) and therefore endometrial scratching does not appear to help women get pregnant from IVF.
There was also no difference seen in other outcomes such ongoing pregnancy, clinical pregnancy, multiple pregnancy, ectopic pregnancy, or miscarriage. The median score for pain from endometrial scratching (on a scale of 0 to 10, with higher scores indicating worse pain) was 3.5 (interquartile range, 1.9 to 6.0).PIP-PCOS recruited women with polycystic ovarian syndrome trying to get pregnant from ovulation induction medication and sexual intercourse. A total of 117 women were randomized. This was less than the number we originally planned to recruit, and therefore the study is limited in what it can conclude. Live birth occurred in 11 (19%) women in the scratch group and 14 (24%) in the sham group, which was not signicantly different. There were no differences between the groups in the secondary outcomes listed above.
PIP-UE recruited women who had unexplained infertility and were trying to get pregnant from sexual intercourse. A total of 220 women underwent randomization. The live birth rate was 9% in the endometrial-scratch group and 7% in the control group, which was not significantly different. There were no differences between the groups in the secondary outcomes listed above.
REC name
South West - Frenchay Research Ethics Committee
REC reference
15/SW/0331
Date of REC Opinion
10 Feb 2016
REC opinion
Further Information Favourable Opinion