Progesterone support,cytokine polymorphisms & risk of OHSS in IVF/ICSI

• Research type

  Research Study

• Full title

  The role of progesterone support and genetic polymorphisms for inflammatory cytokines on the risk of developing ovarian hyperstimulation syndrome (OHSS) in women undergoing In-Vitro fertilisation/Intracytoplasmic sperm injection (IVF, IVF-ICSI) treatment for infertility.

• IRAS ID

  16279

• Contact name

  Vinay Sharma

• Sponsor organisation

  Leeds Teaching Hospitals and University of Leeds

• Eudract number

  2009-012666-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Ovarian Hyperstimulation Syndrome (OHSS) is a serious complication of hormone therapy, commonly used in treatments such as in vitro fertilisation (IVF) & intracytoplasmic sperm injection (ICSI) in order to produce multiple eggs. Rate of OHSS in the general population, i.e. women undergoing fertility treatment is reported to be as high as 30%. Moderate to severe cases occur in 1-8% of women and this in turn may be associated with serious complications such as venous thromboembolism, ascites, pleural and even pericardial effusions. All women, especially younger women and those with polycystic ovary syndrome (PCOS) are 'at risk' but even among 'at risk' women there is a wide variation in the severity of OHSS. Following embryo transfer into the uterus (womb) as matter of routine, treatment with progesterone in different preparations is given to support embryo implantation and early pregnancy. In this randomised controlled study we aim to recruit women undergoing routine IVF or ICSI treatment. We will investigate the impact of different progesterone preparations on OHSS risk and study the genetic profile of various inflammatory biochemical factors that have been associated with OHSS to see if there are differences in women who develop more significant problems compared with those who do not. If successful these tests could be done prior to treatment in order to assess the risk and then treatment can then be modified or individualized. Anecdotal reports show that rate of reported symptoms of OHSS may differ with different forms of progesterone, we also aim to compare absorption rate, corresponding blood levels of the inflammatory biochemical markers & steroid hormones and changes in ovarian morphology after the embryo transfer because it is during this time that symptoms of OHSS appear. The study will take place at the Reproductive medicine unit at Leeds Teaching Hospitals NHS Trust and is expected to last up to 2 years.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/100

• Date of REC Opinion

  30 Sep 2009

• REC opinion

  Further Information Favourable Opinion