- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04973969
Follicular Challenge Test to Predict Response to GnRH Agonist Triggering
GnRH agonist triggering is used during ART in order to reduce the risk of OHSS. Some studies described that in up to 5% of the cycles triggered with GnRH agonist, a lack of respone or suboptimal response was displayed.
The investigators aim to asses the possibility to predict the respone to ovulation triggering by the response to decapeptyl in the follicular phase of the same cycle.
Study Overview
Detailed Description
The investigators will use Decapeptyl on day 2 of menstruation followed by antagonist protocol.
Hormonal proflie including E2, P, LH, FSH will be measured. LH surge and the rest of the hormonal profile will be compared to day after ovulation triggering.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarit Avraham, Dr
- Phone Number: 00972522371126
- Email: sarita@shamir.gov.il
Study Locations
-
-
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Tzrifin, Israel
- Recruiting
- Shamir Medical Center
-
Contact:
- Sarit Avraham, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
patients that undergo fertility preservation
- patients planned to freeze embryos due to PGT or surrogacy --patients at high risk for OHSS
Exclusion Criteria:
- Poor ovarian response
- known hypothalamic- pituitary dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: study group
The participants will recieve decapeptyl 0.2 mg on day 2/3 of the follicular phase.At that day, and at the day after, hormonsl profile will be documented.
The hormonal profile of the day after follicular decapeptyl administration will be compared to the hormonal profile to test the predictive value.
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diagnosis of predictio value
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The response to GnRH triggering
Time Frame: One treatment cycle (each cycle is 28 days) for each participant (up to 28 days).
|
LH levels 10-12 hours after decapeptyl trigger, number of mature oocytes
|
One treatment cycle (each cycle is 28 days) for each participant (up to 28 days).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarit Avraham, Dr, Asaf Harofe Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 0304-20-ASF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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