GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian Cyst

NCTNCT04993924Other id0024-21-ASF

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 15 participants (estimated)
Sponsor: Assaf-Harofeh Medical Center · Other gov
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Israel
Start: 1 May 2021
Primary completion: 1 Mar 2022 (estimated)
Completion: 1 Mar 2023 (estimated)
First posted: 6 Aug 2021
Last update posted: 13 Oct 2021
Conditions: IVF · Ovarian Cysts

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2021202220232024

Ph 4
GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian Cyst
NCT04993924
1 May 2021 to est. 1 Mar 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Cetrorelix Acetate, Ganerelix AcetateDrug

Arms1

Experimental
Participants
Patients will start GnRH antagonist injections \[Cetrotide (cetrolix) or Orgalutran (ganirelix) - depending on their primary prescription\] for 3-6 days

Primary outcomes2

Outcomes the sponsor listed as primary.

Cyst resolution
Time frame · 2 years
Registry description
Number of participants with a resolution/decrease in size of the cystic structure following GnRH antagonist.
Number of oocytes retrieved
Time frame · 2 years
Registry description
cycle outcome - number of oocytes retrieved, of participants following the administration of the GnRH antagonist

Secondary outcomes(2)

Number of patients which had an oocyte in the aspirated cystic content.
Time frame · 2 years
Registry description
cystic content
Comparison of cycle outcome - oocyte number compared to a previous/future cycle cycle outcome compared to a previous cycle
Time frame · 2 years
Registry description
Comparison to a similar cycle of the same patients using similar GT dosages - number of oocytes retrieved.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Antagonist protocol. 2. 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. Exclusion Criteria: 1. Inability to provide informed consent. 2. Oocyte donor

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