Pituitary Down-regulation Before IVF for Women With Endometriosis

NCT01757249 | Terminated Phase 4

• 2 other identifiers: NDOG-12/SC/06452012-004954-27
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  The birth of a live child after 24 gestational weeks

  up to 40 weeks following embryo transfer date

Secondary Outcomes (5)

• IVF Cycle outcomes

  up to 40 weeks following embryo transfer date

• Treatment responses per cycle

  up to one week after egg collection

• 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

Study Arms (2)

Group 1 OCP

EXPERIMENTAL

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)

Group 2 Control

NO INTERVENTION

Control Group - no intervention

Interventions

Combined Oral Contraceptive Pill (Microgynon 30) DRUG

Pre-IVF treatment for 8 weeks

Also known as: Microgynon 30

Group 1 OCP

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Oxford Fertility Unit: collaborator

Study Sites (1)

NDOG, University of Oxford

Oxford, OX4 2HW, United Kingdom

Location

MeSH Terms

Interventions

Contraceptives, Oral, Combined

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Tim Child

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 28, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

GB (1)