GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian Cyst
1 other identifier
interventional
15
1 country
1
Brief Summary
In this study we would like to examine the effect of GnRH antagonist administration at the beginning of the follicular phase in patient presenting with a simple ovarian cyst 25-50 mm. The aim of this intervention is to allow a spontaneous regression of the ovarian cyst (if in nature) while ensuring a pituitary downregulation to prevent the beginning of a leading follicle recruitment. As previous studies using GnRH antagonist pre-treatment prior to GT initiation for other purposes demonstrated positive results (including different patient population) , no deleterious effects are expected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedOctober 13, 2021
October 1, 2021
10 months
February 20, 2021
October 5, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Cyst resolution
Number of participants with a resolution/decrease in size of the cystic structure following GnRH antagonist.
2 years
Number of oocytes retrieved
cycle outcome - number of oocytes retrieved, of participants following the administration of the GnRH antagonist
2 years
Secondary Outcomes (2)
Number of patients which had an oocyte in the aspirated cystic content.
2 years
Comparison of cycle outcome - oocyte number compared to a previous/future cycle cycle outcome compared to a previous cycle
2 years
Study Arms (1)
Participants
EXPERIMENTALPatients will start GnRH antagonist injections \[Cetrotide (cetrolix) or Orgalutran (ganirelix) - depending on their primary prescription\] for 3-6 days
Interventions
3-6 days of 0.25 mg starting on day 2-3 of the menstrual cycle
Eligibility Criteria
You may qualify if:
- Antagonist protocol.
- Presentation for cycle initiation on day 2-3 of the menstrual cycle with a simple ovarian cyst \>25 mm and \< 50mm, and estradiol levels \< 220 pmol/L.
You may not qualify if:
- Inability to provide informed consent.
- Oocyte donor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shamir Medical center
Be’er Ya‘aqov, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Center
Study Record Dates
First Submitted
February 20, 2021
First Posted
August 6, 2021
Study Start
May 1, 2021
Primary Completion
March 1, 2022
Study Completion
March 1, 2023
Last Updated
October 13, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share