Pituitary Down-regulation Before IVF for Women With Endometriosis

This study has been terminated.
(Unable to recruit sufficient participants)
Sponsor:
Collaborator:
Oxford Fertility Unit
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01757249
First received: December 20, 2012
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Fertility
Drug: Combined Oral Contraceptive Pill (Microgynon 30)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Live birth rate [ Time Frame: up to 40 weeks following embryo transfer date ] [ Designated as safety issue: No ]
    The birth of a live child after 24 gestational weeks


Secondary Outcome Measures:
  • IVF Cycle outcomes [ Time Frame: up to 40 weeks following embryo transfer date ] [ Designated as safety issue: No ]
    Cancelled cycles, failed cycles - negative pregnancy test, biochemical pregnancy, clinical pregnancy, miscarriage, stillbirth

  • Treatment responses per cycle [ Time Frame: up to one week after egg collection ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 4 weeks after final embryo transfer ] [ Designated as safety issue: No ]
  • Multiple pregnancy rate [ Time Frame: Up to 6 weeks after final embryo transfer ] [ Designated as safety issue: No ]
  • Number of ectopic pregnancies [ Time Frame: up to 6 weeks after embryo transfer ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Microgynon 30
No Intervention: Group 2 Control
Control Group - no intervention

  Eligibility

Ages Eligible for Study:   19 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757249

Locations
United Kingdom
NDOG, University of Oxford
Oxford, United Kingdom, OX4 2HW
Sponsors and Collaborators
University of Oxford
Oxford Fertility Unit
Investigators
Principal Investigator: Tim Child University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01757249     History of Changes
Other Study ID Numbers: NDOG-12/SC/0645, 2012-004954-27
Study First Received: December 20, 2012
Last Updated: November 11, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Contraceptive Agents
Ethinyl Estradiol-Norgestrel Combination
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on July 31, 2014