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Pituitary Down-regulation Before IVF for Women With Endometriosis

NCT ID: NCT01757249

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Fertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Combined Oral Contraceptive Pill (Microgynon 30)

Intervention Type DRUG

Pre-IVF treatment for 8 weeks

Group 2 Control

Control Group - no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Combined Oral Contraceptive Pill (Microgynon 30)

Pre-IVF treatment for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Microgynon 30

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oxford Fertility Unit

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Child

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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NDOG, University of Oxford

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2012-004954-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NDOG-12/SC/0645

Identifier Type: -

Identifier Source: org_study_id