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GnRH Antagonist Pre-treatment for the Prevention of Asynchronous Follicular Growth

NCT05071339 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-10-08

No results posted yet for this study

Summary

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.

Conditions

  • IVF

Interventions

DRUG

Ganirelix Acetate, Cetrolix Acetate

3-6 days of 0.25mg GnRH antagonist starting day 2-3 of the menstrual cycle prior to the administration of the original protocol.

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-03-01
Completion
2023-03-01
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05071339 on ClinicalTrials.gov