Back to resultsOvulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
GnRH agonist trigger
hCG trigger
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- IVF patients with at least 4 consecutive failures.
- On trigger day, no more than 10 follicles of 12 mm and up
Exclusion Criteria:
- History of moderate or severe OHSS.
Sites / Locations
- IVF Unit, Rambam medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
hCG trigger
GnRH agonist trigger
Arm Description
Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
Outcomes
Primary Outcome Measures
Fetal Heart Activity 1 Month After Oocyte Retrieval
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
Secondary Outcome Measures
Patients Comfort During the Luteal Phase
Full Information
NCT ID
NCT02048891
First Posted
January 27, 2014
Last Updated
May 20, 2015
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT02048891
Brief Title
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.
The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hCG trigger
Arm Type
Active Comparator
Arm Description
Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
Arm Title
GnRH agonist trigger
Arm Type
Experimental
Arm Description
ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
Intervention Type
Drug
Intervention Name(s)
GnRH agonist trigger
Other Intervention Name(s)
Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
Intervention Type
Drug
Intervention Name(s)
hCG trigger
Other Intervention Name(s)
Ovulation trigger with Ovitrelle 250 microgram., Luteal support with daily progesterone gel = Crinone 8%
Primary Outcome Measure Information:
Title
Fetal Heart Activity 1 Month After Oocyte Retrieval
Description
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
Time Frame
1 month after oocyte retrieval
Secondary Outcome Measure Information:
Title
Patients Comfort During the Luteal Phase
Time Frame
During 2 weeks from day of oocyte retrieval
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IVF patients with at least 4 consecutive failures.
On trigger day, no more than 10 follicles of 12 mm and up
Exclusion Criteria:
History of moderate or severe OHSS.
Facility Information:
Facility Name
IVF Unit, Rambam medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
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