A randomised, single blind controlled study assessing the effect of endometrial injury on live birth rate in women who are undergoing an Invitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) cycle.

A randomised, single blind controlled study assessing the effect of luteal phase pipelle endometrial biopsy versus sham biopsy on live birth rate in women who are undergoing an IVF/ICSI cycle.

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001222932

Acronym

The MENDIT Trial: Multicentre endometrial Injury Trial

Enrollment

280

Registered

2011-11-29

Start date

2012-01-01

Completion date

Unknown

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

Implantation of the embryo remains a key rate limiting step for successful outcome in an IVF/ICSI cycle in women with subfertility. Several small and heterogeneous studies have suggested that injury to the endometrium (lining of the uterus) prior to an IVF/ICSI cycle improves the clinical pregnancy rate or live birth rate. The aim of this study is to determine whether a single endometrial biopsy prior to an IVF/ICSI cycle influences the live birth rate in women under 40 years of age who have failed to conceive a pregnancy despite having undergone at least 2 embryo transfers of reasonable quality embryos. The study will be a large, single blind, randomised controlled trial with the above aim, whilst trying to control for many of the confounders present in previous small studies.

Interventions

Patients in the treatment group will undergo speculum examination, the cervix will be wiped with chlorhexidine and pipelle endometrial biopsy taken between luteal days 7 to 10 (days 21 and 24 of a spontaneous 28 day cycle) preceding their IVF stimulated cycle or 4 to 7 days prior to ceasing the combined oral contraceptive pill if using a pill cross-over cycle. This intervention will occur only once and will take approximately five minutes to complete.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 39 Years

Healthy volunteers

Inclusion criteria

A woman requiring IVF/ICSI Age between 18-39 years (up to 40th Birthday) Have undergone at least 2 embryo transfers without conceiving a clinical pregnancy Be ordered a starting dose of r-FSH of 300IU or less Have all previous IVF cycles resulting in 3 or more oocytes BMI 35 or less Both ovaries present Uterine cavity without abnormality as assessed by ultrasound, hysteroscopy or hysterosalpingography

Exclusion criteria

Hysteroscopy or hysterosalpingography or endometrial biopsy within the 3 months prior to study Paricipating in complementary medical intervention Undergoing assisted hatching Current smoker Previous chemotherapy or radiotherapy

Outcome results