Pituitary Down-regulation Before IVF for Women With Endometriosis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Fertility |
Drug: Combined Oral Contraceptive Pill (Microgynon 30) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Live birth rate [ Time Frame: up to 40 weeks following embryo transfer date ] [ Designated as safety issue: No ]The birth of a live child after 24 gestational weeks
- IVF Cycle outcomes [ Time Frame: up to 40 weeks following embryo transfer date ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Multiple pregnancy rate [ Time Frame: Up to 6 weeks after final embryo transfer ] [ Designated as safety issue: No ]
- Number of ectopic pregnancies [ Time Frame: up to 6 weeks after embryo transfer ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 19 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participant is willing and able to give informed consent for participation in the study.
- Female aged 18 to 39 years old.
- Intending to undergo treatment with a first, second or third cycle of IVF or IVF-ICSI.
- Diagnosed with any degree of endometriosis or endometrioma.
- Participants must meet World Health Organisation Group 1 or 2 eligibility requirements for Combined Oral Contraceptive use.
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.
- The patient has already undergone 3 or more IVF or IVF-ICSI cycles.
- Patients who are already taking any medication to treat endometriosis such as progestins, OCP, Gonadotrophin Releasing Hormone agonists, danazol, mirena, etc. or who have done so within the last 3 months.
- Participants who do not meet World Health Organisation Group 1 or 2 eligibility requirements for Combined Oral Contraceptive use.
Contacts and Locations More Information
No publications provided
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT01757249 History of Changes |
| Other Study ID Numbers: | NDOG-12/SC/0645, 2012-004954-27 |
| Study First Received: | December 20, 2012 |
| Last Updated: | December 27, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female Contraceptive Agents Ethinyl Estradiol-Norgestrel Combination Ethinyl estradiol, levonorgestrel drug combination Contraceptives, Oral Contraceptives, Oral, Combined Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital |
ClinicalTrials.gov processed this record on June 17, 2013