Pituitary Down-regulation Before IVF for Women With Endometriosis

Sponsor

University of Oxford (Other)

Overall Status

Terminated

CT.gov ID

NCT01757249

Collaborator

Oxford Fertility Unit (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fertility	Drug: Combined Oral Contraceptive Pill (Microgynon 30)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Microgynon 30
No Intervention: Group 2 Control Control Group - no intervention

Arm

Intervention/Treatment

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 Names:

Microgynon 30

No Intervention: Group 2 Control

Control Group - no intervention

Outcome Measures

Primary Outcome Measures

Live birth rate [up to 40 weeks following embryo transfer date]
The birth of a live child after 24 gestational weeks

Secondary Outcome Measures

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]
Multiple pregnancy rate [Up to 6 weeks after final embryo transfer]
Number of ectopic pregnancies [up to 6 weeks after embryo transfer]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.