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.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: 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. CONDITION: Infertility PRIMARY OUTCOME: Live Birth Rate ; All patients who become pregnant as a result of participating in an IVF program are required to have pregnancy and neonatal outcomes recorded. This data is known as the Australian New Zealand Assisted Reproduction Database and is part of the National Perinatal Statistics Unit. Patients or their doctors are contacted routinely to collect this information. This study requires the same information to be collected. SECONDARY OUTCOME: Biochemical Pregnancy Rate. ; A quantitative serum hCG (using immunoassay) will be performed on Day 14 post oocyte retrieval. Clinical Pregnancy Rate. ; This will be determined by the presence of a gestational sac on transvaginal ultrasound at 7‐8 weeks of pregnancy in those women who have had a positive serum hCG on Day 14. Endometrial Thickness. ; This will be measured by transvaginal ultrasound at the time of oocyte retrieval. Implantation Rate. ; This will be assessed by determining the number of gestational sacs on transvaginal ultrasound at 7‐8 weeks of pregnancy as is part of routine clinical practice for those patients who conceive. 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
Epistemonikos ID: eacfb92a156d40d47dd2df52726c9965cb393b55
First added on: Aug 22, 2024