Pituitary Down-regulation Before IVF for Women With Endometriosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01757249|
Recruitment Status : Terminated (Unable to recruit sufficient participants)
First Posted : December 28, 2012
Last Update Posted : November 13, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Fertility||Drug: Combined Oral Contraceptive Pill (Microgynon 30)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Centre Open-label Randomised Controlled Trial of Long Term Pituitary Down-regulation Before in Vitro Fertilisation for Women With Endometriosis: a Pilot Study|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Group 1 OCP
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)
Pre-IVF treatment for 8 weeks
Other Name: Microgynon 30
No Intervention: Group 2 Control
Control Group - no intervention
- Live birth rate [ Time Frame: up to 40 weeks following embryo transfer date ]The birth of a live child after 24 gestational weeks
- IVF Cycle outcomes [ Time Frame: up to 40 weeks following embryo transfer date ]Cancelled cycles, failed cycles - negative pregnancy test, biochemical pregnancy, clinical pregnancy, miscarriage, stillbirth
- Treatment responses per cycle [ Time Frame: up to one week after egg collection ]No. of follicles aspirated, No. of oocytes retrieved, No. of cleavage embryos obtained, Total dose and duration of Gonadotrophins
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757249
|NDOG, University of Oxford|
|Oxford, United Kingdom, OX4 2HW|
|Principal Investigator:||Tim Child||University of Oxford|