A Phase 4 interventional study of Combined Oral Contraceptive Pill (Microgynon 30) in Fertility, sponsored by University of Oxford. Terminated at 1 site in United Kingdom. Open to female participants aged 19 Years to 39 Years. Per ClinicalTrials.gov, last updated 2013-11-13.
Sponsored by University of Oxford · Phase 4, Interventional, and Treatment
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 5 is below the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
The participant does not understand the English language, or has special communication needs. This is because it is impractical to provide, for this small scale study, information sheets and consent forms in other languages except English.
Combined oral contraceptive pill (OCP) (Microgynon 30) containing Levonorgestrel/Ethinylestradiol 150/30mcg. Taken orally on a continuous regime for 8 weeks, once a day.
Drug: Combined Oral Contraceptive Pill (Microgynon 30)
Control Group - no intervention
Pre-IVF treatment for 8 weeks
Also known as: Microgynon 30
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
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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University of Oxford