Clinical trial NCT01757249: Pituitary Down-regulation Before IVF for Women With Endometriosis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fertility
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford Fertility Unit
First posted: 2012-12-28
Enrollment: 5
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Live birth rate
timeFrame: up to 40 weeks following embryo transfer date
Secondary outcomes:
measure: IVF Cycle outcomes
timeFrame: up to 40 weeks following embryo transfer date
measure: Treatment responses per cycle
timeFrame: up to one week after egg collection
measure: Number of cases of Ovarian Hyperstimulation Syndrome
timeFrame: Up to 4 weeks after final embryo transfer
measure: Multiple pregnancy rate
timeFrame: Up to 6 weeks after final embryo transfer
measure: Number of ectopic pregnancies
timeFrame: up to 6 weeks after embryo transfer
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: NDOG, University of Oxford
Study officials:
affiliation: University of Oxford
name: Tim Child
role: PRINCIPAL_INVESTIGATOR
References: