InfertilityPhase 4CLOVANTNCT01577199
RCT of Low-dose Clomiphene vs. High Dose Gonadotropin Protocol for IVF Poor Responders
A Phase 4 study testing Low-dose Clomiphene and High dose gonadotropins in people with Infertility, run by Weill Medical College of Cornell University.
Trial summary
The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Low-dose Clomiphene and High dose gonadotropins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients age 18-42 undergoing IVF
- AFC <7 (see definition above) and AMH (see definition above) <0.5 and/or prior poor IVF response
Who cannot join
- BMI (body mass index) >30
- PGD (preimplantation genetic diagnosis, in which embryos are biopsied to rule out chromosomal abnormalities)
- Age >42
- Fragile X carriers (a condition associated with premature ovarian aging)
- TESE (Testicular sperm extraction)
- Asherman's syndrome (uterine scarring which can affect implantation and pregnancy)
- Untreated hydrosalpinx (accumulated fluid in the fallopian tube which may be toxic to embryos)
- >6 prior attempted cycles
About this study
Official title: Randomized Prospective Controlled Non-inferiority Trial of Low-dose Clomiphene Based Antagonist Protocol vs. High Dose Gonadotropin/Antagonist Protocol for IVF Poor Responders
The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. This research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.
Read the detailed description
The objective of this protocol is to prospectively evaluate whether a clomid-based, low dose gonadotropin protocol (225 IU) would be non-inferior in terms of mature oocyte yield (eggs that are ready to be fertilized) as compared to a high-dose protocol.
Patients meeting the criteria for poor ovarian response will be consented and randomized to either a stimulation protocol involving pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge (the hormone released by the brain to cause ovulation to occur, which is detectable in urine) followed by oral clomiphene citrate 100mg on days 2-6 of the menstrual cycle and 225 international units of gonadotropins starting on day 5, or to the control group involving the same pretreatment with 0.1mg luteal estradiol patches starting 10 days after the LH surge, with high dose gonadotropins (600IU) alone, starting on day 2 of the cycle. After randomization, patients will undergo routine IVF procedures, monitoring, blood draws, cancellation criteria, oocyte retrieval, and embryo transfer as non-study participants.
- Conditions
- Infertility
- Being tested
- Low-dose Clomiphene, High dose gonadotropins
- Keywords
- IVF, poor responder, low ovarian reserve, ART, ovarian stimulation, IVF protocols
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose ClomipheneDrug
Also called clomiphene citrate with low dose gonadotropins
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed by clomiphene citrate 100mgon days 2-6 of the menstrual cycle with 225 international units of gonadotropins (eg Follistim , Menopur) starting on day 5
High dose gonadotropinsDrug
Also called Gonal F or Follistim
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed high dose gonadotropins (eg. Follistim. Menopur) 600IU starting on day 2 of the cycle
| Study group | Role | What they receive |
|---|---|---|
| High dose gonadotropins | Active comparator | High dose gonadotropins protocol compared to Low-dose Clomiphene Receives: Drug: High dose gonadotropins |
| Low-dose Clomiphene | Experimental | clomid-based, low dose gonadotropin protocol compared to High dose gonadotropins Receives: Drug: Low-dose Clomiphene |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of mature oocytes retrieved
To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders
Measured: 1 year
Secondary outcomes (1)
The number of embryos transferred
To evaluate the number of embryos transferred
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: no subjects recruited
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
- Owen Davis, MD, Principal investigator, WCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577199
- Sponsor's protocol ID
- 1112012095
- Acronym
- CLOVANT
- Status last verified
- Dec 2016
- First submitted
- 11 Apr 2012
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Controlled Non-inferiority Trial of Low-dose Clomiphene Based Antagonist Protocol vs. High Dose Gonadotropin/Antagonist Protocol for IVF Poor Responders
- ClinicalTrials.gov ID
- NCT01577199
- Acronym / sponsor ID
- CLOVANT / 1112012095
- Conditions
- Infertility
- Keywords
- IVF, poor responder, low ovarian reserve, ART, ovarian stimulation, IVF protocols
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subjects recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Apr 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.
The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. This research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.
Detailed description
The objective of this protocol is to prospectively evaluate whether a clomid-based, low dose gonadotropin protocol (225 IU) would be non-inferior in terms of mature oocyte yield (eggs that are ready to be fertilized) as compared to a high-dose protocol.
Patients meeting the criteria for poor ovarian response will be consented and randomized to either a stimulation protocol involving pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge (the hormone released by the brain to cause ovulation to occur, which is detectable in urine) followed by oral clomiphene citrate 100mg on days 2-6 of the menstrual cycle and 225 international units of gonadotropins starting on day 5, or to the control group involving the same pretreatment with 0.1mg luteal estradiol patches starting 10 days after the LH surge, with high dose gonadotropins (600IU) alone, starting on day 2 of the cycle. After randomization, patients will undergo routine IVF procedures, monitoring, blood draws, cancellation criteria, oocyte retrieval, and embryo transfer as non-study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose gonadotropins | Active comparator | Drug: High dose gonadotropinsHigh dose gonadotropins protocol compared to Low-dose Clomiphene |
| Low-dose Clomiphene | Experimental | Drug: Low-dose Clomipheneclomid-based, low dose gonadotropin protocol compared to High dose gonadotropins |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients age 18-42 undergoing IVF
- AFC <7 (see definition above) and AMH (see definition above) <0.5 and/or prior poor IVF response
Key exclusion criteria (8 listed)
- BMI (body mass index) >30
- PGD (preimplantation genetic diagnosis, in which embryos are biopsied to rule out chromosomal abnormalities)
- Age >42
- Fragile X carriers (a condition associated with premature ovarian aging)
- TESE (Testicular sperm extraction)
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 |
|---|---|---|
| Low-dose ClomipheneAlso: clomiphene citrate with low dose gonadotropinsPretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed by clomiphene citrate 100mgon days 2-6 of the menstrual cycle with 225 international units of gonadotropins (eg Follistim , Menopur) starting on day 5 | Drug | Low-dose Clomiphene |
| High dose gonadotropinsAlso: Gonal F or FollistimPretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed high dose gonadotropins (eg. Follistim. Menopur) 600IU starting on day 2 of the cycle | Drug | High dose gonadotropins |
Primary outcome
The number of mature oocytes retrieved
Time frame: 1 year
To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders
1 secondary outcome
The number of embryos transferred
Time frame: 1year
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 16 Dec 2016.
- Center for Reproductive MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Owen Davis, MD principal investigator
WCMC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-dose Clomiphene and High dose gonadotropins in people with Infertility, run by Weill Medical College of Cornell University.
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 2 inclusion and 8 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The number of mature oocytes retrieved (time frame: 1 year). 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 16 Dec 2016.