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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Pipelle for Pregnancy (PIP): study protocols for three randomised controlled trials.

Sarah Lensen1, Wellington Martins2, Carolina Nastri2

  • 1Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand. s.lensen@auckland.ac.nz.

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PubMed
Summary
This summary is machine-generated.

Endometrial injury, a procedure to potentially improve pregnancy rates, is being investigated in three large trials (PIP-IVF, PIP-UE, PIP-PCOS). These trials aim to determine if endometrial scratching effectively increases live birth rates in various infertility contexts.

Keywords:
Endometrial injuryEndometrial receptivityEndometrial scratchingImplantationInflammation

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Area of Science:

  • Reproductive Medicine
  • Clinical Trials
  • Infertility Treatment

Background:

  • Infertility treatments have modest success rates, prompting research into novel interventions.
  • Endometrial injury (scratching) is proposed to enhance pregnancy likelihood in assisted reproduction.
  • Existing evidence for endometrial injury's efficacy is limited by study size and quality.

Purpose of the Study:

  • To evaluate the effectiveness of endometrial injury in increasing live birth probability.
  • To test endometrial injury in three distinct subfertility populations: IVF, unexplained infertility, and PCOS.
  • To address gaps in current knowledge regarding endometrial scratching's utility and applicability.

Main Methods:

  • Three multi-center randomized controlled trials (PIP-IVF, PIP-UE, PIP-PCOS) involving a total of 1470 participants.
  • Participants randomized to endometrial injury via pipelle biopsy or a sham procedure/no intervention.
  • Primary outcome: live birth. Secondary outcomes: ongoing pregnancy, clinical pregnancy, and miscarriage.

Main Results:

  • The PIP trials are ongoing, and results are not yet available.
  • The trials are designed with robust methodologies, including intention-to-treat analysis and allocation concealment.
  • Adequate sample sizes (840 for PIP-IVF, 350 for PIP-UE, 280 for PIP-PCOS) are planned to ensure statistical power.

Conclusions:

  • The PIP trials are expected to provide high-quality evidence on the efficacy of endometrial scratching.
  • Confirmation of a beneficial effect could establish endometrial scratching as a cost-effective infertility treatment.
  • Findings will clarify the role and applicability of endometrial injury in diverse patient groups.