InfertilityPhase 4OMLETNCT00826839
Oral Microdose Lupron Versus Luteal Estradiol Trial in Poor Responder In Vitro Fertilization (IVF) Patients
A Phase 4 study testing Oral contraceptive pill and microdose lupron and E2 patch/antagonist in people with Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Hundreds of thousands of couples in the United States experience infertility each year. When initial measures do not help, some couples require a process called ovarian stimulation and in vitro fertilization (IVF). Usually, a woman produces at most one egg each month. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Oral contraceptive pill and microdose lupron and E2 patch/antagonist
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2012
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females of couples with an indication for IVF who have a history of poor response as defined by one of the following:
- Cancellation of IVF due to inadequate follicular development
- Peak estradiol < 1000 pg/mL
- < 6 oocytes retrieved
- Age ≥18 years at the time of signing informed consent
- Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
- Willing and able to sign informed consent
Who cannot join
- Prior use of the E2/ganirelix or OCP/microdose protocol
- Less than 2 ovaries or any other ovarian abnormality
- Presence of uncorrected unilateral or bilateral hydrosalpinx
- Presence of any clinically relevant pathology affecting the uterine cavity or intramural fibroid ≥ 5cm
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)
- Contraindications for the use of oral contraceptive pills (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)
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- Contraindications for the use of estrogen patches (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)
- Abnormal karyotyping of the patient or her partner (if karyotyping is performed)
- Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol
- Transfer of embryos to the patient not planned (i.e. gestational carrier use planned, embryos to be frozen)
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ronald O. Perlman and Claudia Cohen Center for Reproductive Medicine at Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: A Randomized Controlled Trial of Treatment Protocols to Optimize Outcomes in Poor Responder In Vitro Fertilization (IVF) Patients: E2 Patch/Antagonist Protocol Versus OCP/Microdose Lupron Protocol
Hundreds of thousands of couples in the United States experience infertility each year. When initial measures do not help, some couples require a process called ovarian stimulation and in vitro fertilization (IVF). Usually, a woman produces at most one egg each month. Ovarian stimulation helps these women make more than one egg per month. However, this involves taking hormones that stimulate the ovary to produce many eggs at one time. The stimulatory hormones injected with a small needle. The eggs are removed from the ovary through a surgical procedure and then placed in a dish for fertilization by sperm to form embryos. The embryos are grown in the laboratory then replaced into the woman's uterus 3-5 days later.
The stimulation of the ovaries is important. Some patients undergo ovarian stimulation for IVF but do not respond to the treatment. This is a very difficult situation because even though several ovarian stimulation protocols have been used for poor responder patients, it is not clear which protocol works best. In fact, two of the most commonly used protocols have not been directly compared.
This study will randomize (like flipping a coin) couples with a history of low response who are going to start IVF treatment into two groups. In one group the female partner will use a protocol called "E2 patch/antagonist". These women will use an estrogen patch and injected antagonist for several days before starting injectable fertility medications. The other group will use a protocol called "OCP/microdose". This group of women will use oral contraceptive pills (OCPs) and small doses of lupron along with the other injectable fertility medications. We will then follow their progress to see how many eggs they produce and how many women get pregnant.
Read the detailed description
Patients who have difficulty conceiving naturally often seek medical advice. These patients often undergo initial treatment with insemination using oral or injectable medications. However, if this fails to achieve a pregnancy, patients often undergo in vitro fertilization (IVF). IVF is a process which involves a protocol of injectable medications to stimulate the ovary to produce several eggs at once. These eggs are retrieved under ultrasound guidance and fertilized in the laboratory. After 3-5 days of growth in the laboratory, the appropriate number of embryos is then transferred back to the patient's uterus.
Sometimes, patients who go through ovarian stimulation and IVF do not respond well. These patients have low estrogen levels, few eggs retrieved, and fewer embryos to transfer back to the uterus. Overall, they have lower pregnancy rates than other patients. It is not clear which medication protocol would give them the highest chance of pregnancy. Two protocols, one called the "E2/antagonist" protocol and the other called the "OCP/microdose" protocol, are routinely used in poor responder patients. But, they have never been prospectively compared so it is not possible to say whether one approach is better.
In order to determine which medication protocol results in more pregnancies, we propose to randomize poor responder patients who are scheduled to undergo treatment with IVF to one of these two protocols. These two protocols are already standard care in IVF centers around the world. Following randomization, the clinical care of study participants will be the same as all other IVF patients. Specifically, the adjustment of medication, egg retrieval, and embryo transfer procedures will be identical to non-study patients undergoing IVF.
HYPOTHESIS We hypothesize that the poor responder patients undergoing ovarian stimulation for IVF with the E2/antagonist protocol will have a higher pregnancy rate than those in the OCP/microdose group.
- Conditions
- Infertility
- Being tested
- Oral contraceptive pill and microdose lupron, E2 patch/antagonist
- Keywords
- In vitro fertilization, Poor responder patients, Randomized clinical trial, Estrogen patch, Gonadotropin-releasing hormone antagonist, Oral contraceptive pill, Microdose lupron
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral contraceptive pill and microdose lupronDrug
Also called Ortho-Cept®, Desogen®, Reclipsen™, Apri®
Desogestrel/ethinyl estradiol tablets, 0.15 mg/0.03 mg, one tablet by mouth daily for 14 days Leuprolide acetate 40 µg by subcutaneous injection twice a day during ovarian stimulation (approximately 14 days)
E2 patch/antagonistDrug
Also called Climara®, Ganirelix acetate injection®
Estradiol transdermal system 0.1 mg/day (25 cm2 patch. Patch changed every other day x 3. Final patch left on for about 7 days. Total duration of therapy approximately 14 days.
Gonadotropin-releasing hormone antagonist 0.25 mg subcutaneously every other day for 3 total doses.
| Study group | Role | What they receive |
|---|---|---|
| OCP/MDL | Experimental | Oral contraceptive pills/microdose lupron Receives: Drug: Oral contraceptive pill and microdose lupron |
| E2/antagonist | Experimental | Estradiol patch/gonadotropin-releasing hormone antagonist Receives: Drug: E2 patch/antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: 7 weeks gestation
Secondary outcomes (11)
Cycle cancellation rate
Measured: Cycle completion
Peak estradiol level
Measured: Cycle completion
Ampules of gonadotropins required during ovarian stimulation
Measured: Cycle completion
Number of days of ovarian stimulation
Measured: Cycle completion
Number of oocytes retrieved
Measured: Cycle completion
Number of embryos transferred
Measured: Cycle completion
Number of embryos frozen
Measured: Cycle completion
Embryo grade
Measured: Cycle completion
Implantation rate
Measured: 7 weeks gestation
Miscarriage rate
Measured: 20 weeks gestation
Pregnancy outcome
Measured: Following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2010
- Study completionJan 2012
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zev Rosenwaks, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826839
- Sponsor's protocol ID
- 0810010037
- Acronym
- OMLET
- Status last verified
- Jun 2013
- First submitted
- 21 Jan 2009
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Treatment Protocols to Optimize Outcomes in Poor Responder In Vitro Fertilization (IVF) Patients: E2 Patch/Antagonist Protocol Versus OCP/Microdose Lupron Protocol
- ClinicalTrials.gov ID
- NCT00826839
- Acronym / sponsor ID
- OMLET / 0810010037
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Poor responder patients, Randomized clinical trial, Estrogen patch, Gonadotropin-releasing hormone antagonist, Oral contraceptive pill, Microdose lupron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Jan 2009 (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.
Hundreds of thousands of couples in the United States experience infertility each year. When initial measures do not help, some couples require a process called ovarian stimulation and in vitro fertilization (IVF). Usually, a woman produces at most one egg each month. Ovarian stimulation helps these women make more than one egg per month. However, this involves taking hormones that stimulate the ovary to produce many eggs at one time. The stimulatory hormones injected with a small needle. The eggs are removed from the ovary through a surgical procedure and then placed in a dish for fertilization by sperm to form embryos. The embryos are grown in the laboratory then replaced into the woman's uterus 3-5 days later.
The stimulation of the ovaries is important. Some patients undergo ovarian stimulation for IVF but do not respond to the treatment. This is a very difficult situation because even though several ovarian stimulation protocols have been used for poor responder patients, it is not clear which protocol works best. In fact, two of the most commonly used protocols have not been directly compared.
This study will randomize (like flipping a coin) couples with a history of low response who are going to start IVF treatment into two groups. In one group the female partner will use a protocol called "E2 patch/antagonist". These women will use an estrogen patch and injected antagonist for several days before starting injectable fertility medications. The other group will use a protocol called "OCP/microdose". This group of women will use oral contraceptive pills (OCPs) and small doses of lupron along with the other injectable fertility medications. We will then follow their progress to see how many eggs they produce and how many women get pregnant.
Detailed description
Patients who have difficulty conceiving naturally often seek medical advice. These patients often undergo initial treatment with insemination using oral or injectable medications. However, if this fails to achieve a pregnancy, patients often undergo in vitro fertilization (IVF). IVF is a process which involves a protocol of injectable medications to stimulate the ovary to produce several eggs at once. These eggs are retrieved under ultrasound guidance and fertilized in the laboratory. After 3-5 days of growth in the laboratory, the appropriate number of embryos is then transferred back to the patient's uterus.
Sometimes, patients who go through ovarian stimulation and IVF do not respond well. These patients have low estrogen levels, few eggs retrieved, and fewer embryos to transfer back to the uterus. Overall, they have lower pregnancy rates than other patients. It is not clear which medication protocol would give them the highest chance of pregnancy. Two protocols, one called the "E2/antagonist" protocol and the other called the "OCP/microdose" protocol, are routinely used in poor responder patients. But, they have never been prospectively compared so it is not possible to say whether one approach is better.
In order to determine which medication protocol results in more pregnancies, we propose to randomize poor responder patients who are scheduled to undergo treatment with IVF to one of these two protocols. These two protocols are already standard care in IVF centers around the world. Following randomization, the clinical care of study participants will be the same as all other IVF patients. Specifically, the adjustment of medication, egg retrieval, and embryo transfer procedures will be identical to non-study patients undergoing IVF.
HYPOTHESIS We hypothesize that the poor responder patients undergoing ovarian stimulation for IVF with the E2/antagonist protocol will have a higher pregnancy rate than those in the OCP/microdose group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCP/MDL | Experimental | Drug: Oral contraceptive pill and microdose lupronOral contraceptive pills/microdose lupron |
| E2/antagonist | Experimental | Drug: E2 patch/antagonistEstradiol patch/gonadotropin-releasing hormone antagonist |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females of couples with an indication for IVF who have a history of poor response as defined by one of the following:
- Cancellation of IVF due to inadequate follicular development
- Peak estradiol < 1000 pg/mL
- < 6 oocytes retrieved
- Age ≥18 years at the time of signing informed consent
Key exclusion criteria (11 listed)
- Prior use of the E2/ganirelix or OCP/microdose protocol
- Less than 2 ovaries or any other ovarian abnormality
- Presence of uncorrected unilateral or bilateral hydrosalpinx
- Presence of any clinically relevant pathology affecting the uterine cavity or intramural fibroid ≥ 5cm
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)
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 |
|---|---|---|
| Oral contraceptive pill and microdose lupronAlso: Ortho-Cept®, Desogen®, Reclipsen™, Apri®Desogestrel/ethinyl estradiol tablets, 0.15 mg/0.03 mg, one tablet by mouth daily for 14 days Leuprolide acetate 40 µg by subcutaneous injection twice a day during ovarian stimulation (approximately 14 days) | Drug | OCP/MDL |
| E2 patch/antagonistAlso: Climara®, Ganirelix acetate injection®Estradiol transdermal system 0.1 mg/day (25 cm2 patch. Patch changed every other day x 3. Final patch left on for about 7 days. Total duration of therapy approximately 14 days. Gonadotropin-releasing hormone antagonist 0.25 mg subcutaneously every other day for 3 total doses. | Drug | E2/antagonist |
Primary outcome
Pregnancy rate
Time frame: 7 weeks gestation
11 secondary outcomes
Cycle cancellation rate
Time frame: Cycle completion
Peak estradiol level
Time frame: Cycle completion
Ampules of gonadotropins required during ovarian stimulation
Time frame: Cycle completion
Number of days of ovarian stimulation
Time frame: Cycle completion
Number of oocytes retrieved
Time frame: Cycle completion
Number of embryos transferred
Time frame: Cycle completion
Number of embryos frozen
Time frame: Cycle completion
Embryo grade
Time frame: Cycle completion
Implantation rate
Time frame: 7 weeks gestation
Miscarriage rate
Time frame: 20 weeks gestation
Pregnancy outcome
Time frame: Following delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- The Ronald O. Perlman and Claudia Cohen Center for Reproductive Medicine at Weill Cornell Medical CollegeLink provided by the sponsor.
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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.
Zev Rosenwaks, M.D. principal investigator
Weill Medical College of Cornell University
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 Oral contraceptive pill and microdose lupron and E2 patch/antagonist in people with Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 25 Jun 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 States. 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 withdrawn before enrolling participants, so there are no results.
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?
Pregnancy rate (time frame: 7 weeks gestation). 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 25 Jun 2013.