FertilityPhase 4NCT01757249
Pituitary Down-regulation Before IVF for Women With Endometriosis
A Phase 4 study testing Combined Oral Contraceptive Pill (Microgynon 30) in people with Fertility, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Fertility
- What is being tested?
- Combined Oral Contraceptive Pill (Microgynon 30)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Combined Oral Contraceptive Pill (Microgynon 30)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Oral Contraceptive Pill (Microgynon 30)Drug
Also called Microgynon 30
Pre-IVF treatment for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Combined Oral Contraceptive Pill (Microgynon 30) |
| Group 2 Control | No intervention | Control Group - no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
The birth of a live child after 24 gestational weeks
Measured: up to 40 weeks following embryo transfer date
Secondary outcomes (5)
IVF Cycle outcomes
Cancelled cycles, failed cycles - negative pregnancy test, biochemical pregnancy, clinical pregnancy, miscarriage, stillbirth
Measured: up to 40 weeks following embryo transfer date
Treatment responses per cycle
No. of follicles aspirated, No. of oocytes retrieved, No. of cleavage embryos obtained, Total dose and duration of Gonadotrophins
Measured: up to one week after egg collection
Number of cases of Ovarian Hyperstimulation Syndrome
Measured: Up to 4 weeks after final embryo transfer
Multiple pregnancy rate
Measured: Up to 6 weeks after final embryo transfer
Number of ectopic pregnancies
Measured: up to 6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Unable to recruit sufficient participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Fertility Unit
- Responsible party
- Sponsor
- Investigators
- Tim Child, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757249
- Sponsor's protocol ID
- NDOG-12/SC/0645
- Other IDs
- 2012-004954-27
- Status last verified
- Nov 2013
- First submitted
- 20 Dec 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01757249
- Acronym / sponsor ID
- NDOG-12/SC/0645
- Conditions
- Fertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient participants
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford Fertility Unit
- Study start
- Jan 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 OCP | Experimental | Drug: Combined Oral Contraceptive Pill (Microgynon 30)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 2 Control | No intervention | –Control Group - no intervention |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Oral Contraceptive Pill (Microgynon 30)Also: Microgynon 30Pre-IVF treatment for 8 weeks | Drug | Group 1 OCP |
Primary outcome
Live birth rate
Time frame: up to 40 weeks following embryo transfer date
The birth of a live child after 24 gestational weeks
5 secondary outcomes
IVF Cycle outcomes
Time frame: up to 40 weeks following embryo transfer date
Treatment responses per cycle
Time frame: up to one week after egg collection
Number of cases of Ovarian Hyperstimulation Syndrome
Time frame: Up to 4 weeks after final embryo transfer
Multiple pregnancy rate
Time frame: Up to 6 weeks after final embryo transfer
Number of ectopic pregnancies
Time frame: up to 6 weeks after embryo transfer
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Child principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined Oral Contraceptive Pill (Microgynon 30) in people with Fertility, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit sufficient participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: up to 40 weeks following embryo transfer date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.