Pituitary Down-regulation Before IVF for Women With Endometriosis

Fertility Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01757249
• Other study ID #: NDOG-12/SC/0645
• Secondary ID: 2012-004954-27
• Status: Terminated
• Phase: Phase 4
• First received: December 20, 2012
• Last updated: November 11, 2013
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 39 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Fertility

Intervention

Drug:
• Combined Oral Contraceptive Pill (Microgynon 30)
Pre-IVF treatment for 8 weeks

Locations

Country	Name	City	State
United Kingdom	NDOG, University of Oxford	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford Fertility Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	The birth of a live child after 24 gestational weeks	up to 40 weeks following embryo transfer date	No
Secondary	IVF Cycle outcomes	Cancelled cycles, failed cycles - negative pregnancy test, biochemical pregnancy, clinical pregnancy, miscarriage, stillbirth	up to 40 weeks following embryo transfer date	No
Secondary	Treatment responses per cycle	No. of follicles aspirated, No. of oocytes retrieved, No. of cleavage embryos obtained, Total dose and duration of Gonadotrophins	up to one week after egg collection	No
Secondary	Number of cases of Ovarian Hyperstimulation Syndrome		Up to 4 weeks after final embryo transfer	No
Secondary	Multiple pregnancy rate		Up to 6 weeks after final embryo transfer	No
Secondary	Number of ectopic pregnancies		up to 6 weeks after embryo transfer	No