MODA Trial Version 1.0
Research type
Research Study
Full title
A prospective randomized controlled trial of modified downregulation vs. standard treatment for women with moderate/severe adenomyosis of the uterus prior to frozen-thawed embryo transfer.
IRAS ID
245873
Contact name
Dimitrios Mavrelos
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 3 days
Research summary
Adenomyosis is a benign condition of the womb caused by the presence of tissue from the inner part womb (the endometrium) in the outer, muscular part of the womb (the myometrium). It can be diagnosed by pelvic ultrasound during routine fertility workup. Adenomyosis is present in up to 1 in 5 women. The presence of moderate/severe adenomyosis in the uterus has recently been found to significantly reduce the chance of conception during IVF.
The purpose of this study is to examine whether we can improve the chance of clinical pregnancy in these women by modifying the medical protocol during IVF treatment.
IVF involves an initial period of downregulation to suppress the ovaries and prevent premature ovulation. Hormone injections are then used to stimulate a woman’s ovaries to produce eggs which are removed by a minor operation. The harvested eggs are mixed with sperm to create embryos in the laboratory. These embryos are replaced in the womb a few days after they are created. Any remaining embryos are frozen such that they can be thawed and transferred at a later date.
We hypothesise that a prolonged downregulation regimen would reduce the inflammatory reaction in the endometrium of women with adenomyosis, thus increasing the chance of implantation after embryo transfer
Consenting patients will be randomized to one of two protocols (A - standard protocol vs. B - prolonged downregulation protocol). We will take uterine flushings for laboratory analysis to examine whether there is suppression of the endometrial inflammatory reaction with prolonged downregulation. Women will be offered a questionnaire before and after IVF to assess for an in adenomyosis symptoms with prolonged downregulation.
The primary outcome of the study is clinical pregnancy. Secondary outcomes are miscarriage, gestational age at delivery, birthweight at delivery.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1567
Date of REC Opinion
16 Oct 2019
REC opinion
Favourable Opinion