Pituitary Down-regulation Before IVF for Women With Endometriosis

Phase 4

Terminated

• Conditions: Fertility
• Interventions: Drug: Combined Oral Contraceptive Pill (Microgynon 30)

• Registration Number: NCT01757249
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2012-12-28
• Study Start: 2013-01
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 OCP	Combined Oral Contraceptive Pill (Microgynon 30)	Combined oral contraceptive pill (OCP) (Microgynon 30) containing Levonorgestrel/Ethinylestradiol 150/30mcg. Taken orally on a continuous regime for 8 weeks, once a day.

Primary Outcome Measures

Name	Time	Method
Live birth rate	up to 40 weeks following embryo transfer date	The birth of a live child after 24 gestational weeks

Secondary Outcome Measures

Name	Time	Method
Number of ectopic pregnancies	up to 6 weeks after embryo transfer
Multiple pregnancy rate	Up to 6 weeks after final embryo transfer
IVF Cycle outcomes	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	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	Up to 4 weeks after final embryo transfer

Trial Locations

Locations (1)

NDOG, University of Oxford; 🇬🇧 Oxford, United Kingdom