Study of Dual Trigger Ovulation in Oocyte Donors (DUALTRIGGER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01443546
First received: August 23, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: HCG
Drug: Lupron Trigger
Drug: Dual Trigger
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Trial of Dual Trigger Ovulation in Oocyte Donors

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Number of Subjects Having Adverse Events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of mature oocytes retrieved [ Time Frame: 1 day post ovulation ] [ Designated as safety issue: No ]
    Number of mature oocytes retrieved will assess the efficacy of the intervention

  • Pregnancies per Transfer [ Time Frame: 4 weeks post retrieval ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 180
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: hCG
standard dose of hCG for ovulation trigger
Drug: HCG
hCG Trigger
Active Comparator: Lupron Trigger
Leuprolide acetate 2 mg ovulation trigger
Drug: Lupron Trigger
leuprolide acetate 2 mg SQ
Experimental: Dual Trigger
Lupron and hCG combined ovulation trigger
Drug: Dual Trigger
a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443546

Contacts
Contact: Ina Cholst, M.D. 646-962-2764 icholst@med.cornell.edu
Contact: Rodriq Stubbs, N.P. 646-962-3276 res2011@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College- Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine Recruiting
New York, New York, United States, 10021
Contact: Rodriq Stubbs, NP    646-962-3276    res2011@med.cornell.edu   
Principal Investigator: Ina Cholst, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01443546     History of Changes
Other Study ID Numbers: 1011011394
Study First Received: August 23, 2011
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
oocyte donor
oocyte recipient
ovulation trigger

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 29, 2014