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Pituitary Down-regulation Before IVF for Women With Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01757249
Recruitment Status : Terminated (Unable to recruit sufficient participants)
First Posted : December 28, 2012
Last Update Posted : November 13, 2013
Oxford Fertility Unit
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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 Name: Microgynon 30

No Intervention: Group 2 Control
Control Group - no intervention

Primary Outcome Measures :
  1. Live birth rate [ Time Frame: up to 40 weeks following embryo transfer date ]
    The birth of a live child after 24 gestational weeks

Secondary Outcome Measures :
  1. IVF Cycle outcomes [ Time Frame: up to 40 weeks following embryo transfer date ]
    Cancelled cycles, failed cycles - negative pregnancy test, biochemical pregnancy, clinical pregnancy, miscarriage, stillbirth

  2. Treatment responses per cycle [ Time Frame: 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

  3. Number of cases of Ovarian Hyperstimulation Syndrome [ Time Frame: Up to 4 weeks after final embryo transfer ]
  4. Multiple pregnancy rate [ Time Frame: Up to 6 weeks after final embryo transfer ]
  5. Number of ectopic pregnancies [ Time Frame: up to 6 weeks after embryo transfer ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01757249

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United Kingdom
NDOG, University of Oxford
Oxford, United Kingdom, OX4 2HW
Sponsors and Collaborators
University of Oxford
Oxford Fertility Unit
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Principal Investigator: Tim Child University of Oxford
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Responsible Party: University of Oxford Identifier: NCT01757249    
Other Study ID Numbers: NDOG-12/SC/0645
2012-004954-27 ( EudraCT Number )
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Genital Diseases, Female
Contraceptive Agents
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital