- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02048891
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel, 31096
- IVF Unit, Rambam medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: hCG trigger
Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
|
Other Names:
|
Experimental: GnRH agonist trigger
ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal Heart Activity 1 Month After Oocyte Retrieval
Time Frame: 1 month after oocyte retrieval
|
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
|
1 month after oocyte retrieval
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patients Comfort During the Luteal Phase
Time Frame: During 2 weeks from day of oocyte retrieval
|
During 2 weeks from day of oocyte retrieval
|
Collaborators and Investigators
Sponsor
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infertility
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Luteolytic Agents
- Progestins
- Triptorelin Pamoate
- Progesterone
Other Study ID Numbers
- RMB-0427-13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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