- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01443546
Study of Dual Trigger Ovulation in Oocyte Donors (DUALTRIGGER)
A Randomized Prospective Trial of Dual Trigger Ovulation in Oocyte Donors
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medical College- Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: hCG
standard dose of hCG for ovulation trigger
|
hCG Trigger
|
ACTIVE_COMPARATOR: Lupron Trigger
Leuprolide acetate 2 mg ovulation trigger
|
leuprolide acetate 2 mg SQ
|
EXPERIMENTAL: Dual Trigger
Lupron and hCG combined ovulation trigger
|
a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 month
|
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.
|
7 days post retrieval
|
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.
|
7 days post retrieval
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Mature Oocytes Retrieved
Time Frame: 1 day post ovulation
|
Number of mature oocytes retrieved will assess the efficacy of the intervention
|
1 day post ovulation
|
Pregnancies Per Transfer
Time Frame: 4 weeks post retrieval
|
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.
|
4 weeks post retrieval
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1011011394
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey
Clinical Trials on HCG
-
Royan InstituteCompletedInfertilityIran, Islamic Republic of
-
Wael Elbanna ClinicNational Research Centre, EgyptRecruitingStudy to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by PipelleFemale InfertilityEgypt
-
Sohag UniversityRecruitingWoman With Tubal Ectopic PregnancyEgypt
-
Assaf-Harofeh Medical CenterUnknown
-
Assaf-Harofeh Medical CenterCompletedRetained Products of ConceptionIsrael
-
AZ Jan Palfijn GentOnze Lieve Vrouw HospitalCompletedInfertility | PCOSBelgium
-
IBSA Institut Biochimique SACompleted
-
Aristotle University Of ThessalonikiCompleted