Trial · Interventional
Status unknownPhase 4Registry dataGnRH Antagonist Pre-treatment for the Prevention of Asynchronous Follicular Growth
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 Apr 2021
- Primary completion
- 1 Mar 2023 (estimated)
- Completion
- 1 Mar 2023 (estimated)
- First posted
- 8 Oct 2021
- Last update posted
- 8 Oct 2021
- Conditions
- IVF
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
GnRH Antagonist Pre-treatment for the Prevention of Asynchronous Follicular Growth
NCT050713391 Apr 2021 to est. 1 Mar 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In the study the investigators would like to examine the effect of GnRH antagonist administration at the beginning of the follicular phase in patients presenting with high baseline estradiol levels of 200 pmol/L or above with a leading follicle of 11-13 mm. In the unit's practice, patients presenting for cycle initiation with a leading follicle \> 10 in the presence of E2 \> 200 pmol/L (54 pg/ml) are deferred and receive a priming antagonist protocol in their sequential cycle. The aim of this intervention is to suppress FSH levels at the beginning of the cycle thus preventing estradiol secretion of the leading follicle. This may contribute to better synchronization of the remaining antral follicles cohort and allow for a better cycle outcome instead of cancellation or one-month postponement. As previous studies using GnRH antagonist pre-treatment prior to GT initiation for synchronization purposes demonstrated positive results (including different patient population) , no deleterious effects are expected.
Interventions
- Ganirelix Acetate, Cetrolix AcetateDrug
Arms1
Experimental
Participants
Patients treated at the IVF unit at Shamir Medical Center planned for an antagonist cycle will undergo blood test and US exam at day 2-3 of their menstrual cycle. Patients will be recruited if a leading follicle 10-13 is shown in the presence of E2 \> 200-350 pmol/L. Patients will start GnRH antagonist injections \[Cetrotide (cetrolix) or Orgalutran (ganirelix) - depending on their primary prescription\] for 3-5 days intervention.
Primary outcomes1
Outcomes the sponsor listed as primary.
Synchronization of follicles
Time frame · 2 year
Registry description
Ratio of number of large (\>15 mm) to small (\<10-15mm) follicles.
Secondary outcomes(3)
Number of mature oocytes that originate from the leading follicles
Time frame · 2 year
Registry description
the absolute number of mature oocytes
Ratio of mature oocytes out of number of follicles
Time frame · 2 year
Registry description
Number of actual oocyte yield (mature oocytes) out of expected yield (number of large follicles).
Number of oocytes compared to a previous cycle
Time frame · 2 years
Registry description
Number of oocytes in the current cycle compared to the number of oocytes in a previous or future cycle using a different protocol
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.
A trial that is still running, or that stopped early, may post results later.
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
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