Pipelle for pregnancy in women undergoing single, autologous, embryo transfer

A randomised controlled trial assessing the effect of endometrial pipelle biopsy vs. no intervention on live birth rate in women undergoing autologous embryo transfer.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000626662

Acronym

PIP-IVF

Enrollment

1364

Registered

2014-06-13

Start date

2014-06-20

Completion date

2017-06-02

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A number of studies have been published which appear to show that performing an endometrial biopsy results in an increase in pregnancy and live birth rates. Most of the studies have been conducted in a focussed subgroup of women, such as those with recurrent implantation failure, and there is little data available on the utility of endometrial biopsy prior to frozen-thaw embryo transfer. To address these limitations, PIP-IVF is a pragmatic randomised trial recruiting all women undergoing autologous embryo transfer, and has been powered to allow detection of subgroup effects such women undergoing their first IVF cycle and women undergoing frozen-thaw transfers.

Interventions

Women randomised to the intervention arm will undergo a single endometrial pipelle biopsy performed between day 3 of the natural menstrual cycle preceding their embryo transfer cycle and day 3 of the menstrual cycle in which embryo transfer is planned

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Women planning to undergo autologous embryo transfer with any indication of subfertility

Exclusion criteria

1. Have had any disruptive instrumentation within the uterine cavity (e.g. hysteroscopy, hysterosalpingogram, laparoscopy, surgically managed miscarriage or endometrial biopsy) within three months prior to day one of the planned embryo transfer cycle, or planning to undergo a procedure involving disruptive instrumentation at any stage during the study. Embryo transfer and intrauterine insemination procedures are not considered to cause disruptive instrumentation 2. Entered previously into this study or participation in another trial in the last 30 days 3. Any contraindication to endometrial biopsy, being pregnant and/or carrying a pregnancy to term 4. Not planning an embryo transfer (e.g. fertility preservation or planned freeze-all cycles)

Outcome results