Endometriosis is a hormone dependent disease of women, in which endometrial tissue (the cells which line the uterus or womb) are found outside the uterus (womb). Some women with endometriosis may be infertile. However, treatments for infertility such as in vitro fertilization (IVF) or IVF with intracytoplasmic sperm injection (IVF-ICSI) appear to be less successful, i.e. the pregnancy rates are lower, for women with endometriosis than for women who may be infertile for other reasons. Since endometriosis is hormone dependent, it has been suggested that suppressing the activity of hormones produced by the ovaries (which affect endometrial growth) may inactivate endometriosis and so increase the chances of pregnancy. Recently it has been proposed that taking the oral contraceptive pill (OCP) for 6 to 8 weeks before IVF or IVF-ICSI treatment could be used for this purpose. For our study, which is a randomised controlled trial, women with endometriosis meeting the study criteria planning to undergo IVF or IVF-ICSI at the Oxford Fertility Unit will be recruited. Study participants will be randomised into 2 arms: experimental group and control group. The experimental group will be instructed to complete an 8 week course of OCP before beginning standard IVF treatment. The control group do not take any study medication before beginning standard IVF treatment. The IVF or IVF-ICSI treatment for both groups is not altered by participation in the study. The aim of the study will be to determine if pretreatment with OCP improves IVF or IVF-ICSI success rates, such as live birth and pregnancy rates, in patients who suffer from endometriosis. The study is funded by the Oxford Fertility Unit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Pre-IVF treatment for 8 weeks
NDOG, University of Oxford
Oxford, United Kingdom
Live birth rate
The birth of a live child after 24 gestational weeks
Time frame: up to 40 weeks following embryo transfer date
IVF Cycle outcomes
Cancelled cycles, failed cycles - negative pregnancy test, biochemical pregnancy, clinical pregnancy, miscarriage, stillbirth
Time frame: up to 40 weeks following embryo transfer date
Treatment responses per cycle
No. of follicles aspirated, No. of oocytes retrieved, No. of cleavage embryos obtained, Total dose and duration of Gonadotrophins
Time frame: up to one week after egg collection
Number of cases of Ovarian Hyperstimulation Syndrome
Time frame: Up to 4 weeks after final embryo transfer
Multiple pregnancy rate
Time frame: Up to 6 weeks after final embryo transfer
Number of ectopic pregnancies
Time frame: up to 6 weeks after embryo transfer
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