InfertilityPhase 4DUALTRIGGERNCT01443546
Study of Dual Trigger Ovulation in Oocyte Donors
A Phase 4 study testing HCG, Lupron Trigger and Dual Trigger in people with Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The project is a randomized, controlled, prospective study of oocyte donors comparing the safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- HCG, Lupron Trigger and Dual Trigger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Donors
- Young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements for donation.
- Recipients
- Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements to be recipients of donated eggs.
Who cannot join
- Donors
- Less than 2 ovaries or any other significant ovarian abnormality
- Does not meet current FDA or program requirements for donation.
- A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)
- A contraindication for the use of oral contraceptive pills (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)
- Known gene defects, genetic abnormalities or abnormal karyotype
Show all 10Show fewer
- Contraindication or hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol
- Inability to give informed consent
- Donors who, because of their place of residence or personal situation, would not be able to commit to all required time points including the one extra visit required by study participation.
- The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College- Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine
New York, New York, 10021
About this study
Official title: A Randomized Prospective Trial of Dual Trigger Ovulation in Oocyte Donors
The project is a randomized, controlled, prospective study of oocyte donors comparing the safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone.
Read the detailed description
The study population will consist of young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and who meet FDA and program requirements for donation.
Participants will be randomized to one of the three treatment interventions for triggering ovulation: 1) a standard dose of hCG, 2) leuprolide acetate 2 mg alone, or 3) a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
Study participants who choose to repeat oocyte donation during the course of the study trial, and who consent to participate in the trial again, will be randomized in a cross-over manner for any subsequent trials.
Following randomization, the clinical care of study subjects will be the same as for non-participant oocyte donors. Participants in all three study arms will undergo standard ovarian stimulation protocol with gonadotropins, standard individualized adjustment of medication dose, standard criteria for administration of the ovulation trigger dose, and standard egg retrieval procedure.
The recipient population will be recruited from women, age 18 to 55, who present to our center wishing to become pregnant using donor oocytes. All prospective participants who meet the Center for Reproductive Medicine (CRM) criteria be recipients of donated eggs will be eligible to participate, should they wish to do so.
If a prospective recipient consents to participate in the study, then she would be matched with either a donor who is not participating in the study (and is receiving one of our standard triggers for ovulation) or a donor who is participating in the study and whose medication to trigger ovulation has been randomized into one of three groups: standard dose hCG, Leuprolide acetate, or a combination of low dose hCG and Leuprolide acetate.
A recipient who chooses to participate in the study will have no additional tests or procedures over the ones that she would normally do in order to receive donated eggs.
- Conditions
- Infertility
- Being tested
- HCG, Lupron Trigger, Dual Trigger
- Keywords
- oocyte donor, oocyte recipient, ovulation trigger
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCGDrug
hCG Trigger
Lupron TriggerDrug
leuprolide acetate 2 mg SQ
Dual TriggerDrug
a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
| Study group | Role | What they receive |
|---|---|---|
| hCG | Active comparator | standard dose of hCG for ovulation trigger Receives: Drug: HCG |
| Lupron Trigger | Active comparator | Leuprolide acetate 2 mg ovulation trigger Receives: Drug: Lupron Trigger |
| Dual Trigger | Experimental | Lupron and hCG combined ovulation trigger Receives: Drug: Dual Trigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Having Adverse Events
Any donor having a serious complication such as severe hyperstimulation syndrome, ovarian torsion, infection or peritoneal bleeding will be recorded
Measured: 1 month
Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities
Subjects will complete a brief questionnaire on post retrieval day 7. They will state how many days after retrieval they were able to resume their usual activities.
Measured: 7 days post retrieval
Ovarian Volume
Ovarian volume of both ovaries will be measured by ultrasound on post op day number 7. Measurements will be taken in three different dimensions and volume calculated from those measurements.
Measured: 7 days post retrieval
Secondary outcomes (2)
Number of Mature Oocytes Retrieved
Number of mature oocytes retrieved will assess the efficacy of the intervention
Measured: 1 day post ovulation
Pregnancies Per Transfer
Pregnancy rate per transfer will be assessed by hCG level on day 14 post retrieval and clinical pregnancy rate will be assessed by ultrasound on day 28 post retrieval. This will additionally assess efficacy of intervention.
Measured: 4 weeks post retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startJan 2013
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Unable to complete accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443546
- Sponsor's protocol ID
- 1011011394
- Acronym
- DUALTRIGGER
- Status last verified
- Jun 2019
- First submitted
- 23 Aug 2011
- Last updated
- 26 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trial of Dual Trigger Ovulation in Oocyte Donors
- ClinicalTrials.gov ID
- NCT01443546
- Acronym / sponsor ID
- DUALTRIGGER / 1011011394
- Conditions
- Infertility
- Keywords
- oocyte donor, oocyte recipient, ovulation trigger
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete accrual
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Posted 22 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is a randomized, controlled, prospective study of oocyte donors comparing the safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone.
Detailed description
The study population will consist of young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and who meet FDA and program requirements for donation.
Participants will be randomized to one of the three treatment interventions for triggering ovulation: 1) a standard dose of hCG, 2) leuprolide acetate 2 mg alone, or 3) a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
Study participants who choose to repeat oocyte donation during the course of the study trial, and who consent to participate in the trial again, will be randomized in a cross-over manner for any subsequent trials.
Following randomization, the clinical care of study subjects will be the same as for non-participant oocyte donors. Participants in all three study arms will undergo standard ovarian stimulation protocol with gonadotropins, standard individualized adjustment of medication dose, standard criteria for administration of the ovulation trigger dose, and standard egg retrieval procedure.
The recipient population will be recruited from women, age 18 to 55, who present to our center wishing to become pregnant using donor oocytes. All prospective participants who meet the Center for Reproductive Medicine (CRM) criteria be recipients of donated eggs will be eligible to participate, should they wish to do so.
If a prospective recipient consents to participate in the study, then she would be matched with either a donor who is not participating in the study (and is receiving one of our standard triggers for ovulation) or a donor who is participating in the study and whose medication to trigger ovulation has been randomized into one of three groups: standard dose hCG, Leuprolide acetate, or a combination of low dose hCG and Leuprolide acetate.
A recipient who chooses to participate in the study will have no additional tests or procedures over the ones that she would normally do in order to receive donated eggs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hCG | Active comparator | Drug: HCGstandard dose of hCG for ovulation trigger |
| Lupron Trigger | Active comparator | Drug: Lupron TriggerLeuprolide acetate 2 mg ovulation trigger |
| Dual Trigger | Experimental | Drug: Dual TriggerLupron and hCG combined ovulation trigger |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Donors
- Young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements for donation.
- Recipients
- Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements to be recipients of donated eggs.
Key exclusion criteria (10 listed)
- Donors
- Less than 2 ovaries or any other significant ovarian abnormality
- Does not meet current FDA or program requirements for donation.
- A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)
- A contraindication for the use of oral contraceptive pills (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)
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 |
|---|---|---|
| HCGhCG Trigger | Drug | hCG |
| Lupron Triggerleuprolide acetate 2 mg SQ | Drug | Lupron Trigger |
| Dual Triggera combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU). | Drug | Dual Trigger |
Primary outcome
Number of Subjects Having Adverse Events
Time frame: 1 month
Any donor having a serious complication such as severe hyperstimulation syndrome, ovarian torsion, infection or peritoneal bleeding will be recorded
Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities
Time frame: 7 days post retrieval
Subjects will complete a brief questionnaire on post retrieval day 7. They will state how many days after retrieval they were able to resume their usual activities.
Ovarian Volume
Time frame: 7 days post retrieval
Ovarian volume of both ovaries will be measured by ultrasound on post op day number 7. Measurements will be taken in three different dimensions and volume calculated from those measurements.
2 secondary outcomes
Number of Mature Oocytes Retrieved
Time frame: 1 day post ovulation
Pregnancies Per Transfer
Time frame: 4 weeks post retrieval
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Infertility
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Active, not recruitingPhase 1/2
Opt-IVF for Personalized Medicine for Normal Responders
Ivf
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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.
The record lists no contact. Use the official record to reach the sponsor.
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 HCG, Lupron Trigger and Dual Trigger 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 4 inclusion and 10 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 26 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 22 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Having Adverse Events (time frame: 1 month). The study lists 3 primary outcomes in all. 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 26 Jun 2019.