Ovarian Response in Oocyte Donors Triggered With GnRH Agonists

Sponsor
Clínica EUGIN (Other)
Overall Status
Completed
CT.gov ID
NCT05109403
Collaborator
(none)
227
1
12.3
18.5

Study Details

Study Description

Brief Summary

The use of agonist of GnRH (aGnRH) trigger to avoid ovarian hyperstimulation syndrome is nowadays widely used. The action of the aGnRH in the hypophysis triggers an LH and FSH surge, which mimicks the natural surge that occurs in the middle of a natural cycle, and thus being able to elicit the ovulation. However, in some patients the aGnRH trigger ends in a poor oocyte recuperation, and that has led some physicians to measure the LH surge after the aGnRH trigger to check its effectiveness.

Even though there is still some discrepancy about the exact cut-off value for a proper LH surge 12h after the aGnRH trigger, most of the published papers report the value of 15UI/L as an adequate threshold under which the results of the pick-up are suboptimal. Other authors even report a value of 52UI/L to predict a decrease in oocyte retrieval and maturity rate and a value of 15UI/L to predict a dramatic decrease in the results.

Some of the abovementioned studies report that the basal LH value or the LH value on the day of the trigger could also be predictive of suboptimal responses. Additionally, some authors have tried to "rescue" the suboptimal patients with a retrigger of hCG, or they have compared those suboptimal responders with patients triggered with both aGnRH and low doses of hCG. In both cases the addition of hCG seems to improve the results.

Most of the scientific bibliography available so far is based on infertile patients undergoing IVF treatments, while in some papers both IVF patients and egg donors have been analyzed. The current study involves exclusively oocyte donation cycles, where the final aim is to identify donors at a high risk of a suboptimal response, and to potentially improve results by potentially adding low doses of hCG (1000 UI).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    227 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Ovarian Response in Oocyte Donors Triggered With GnRH Agonists Depending on the LH Level the Day After the Triggering
    Actual Study Start Date :
    Feb 1, 2021
    Actual Primary Completion Date :
    Jan 26, 2022
    Actual Study Completion Date :
    Feb 10, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    LH post-trigger < 15 UI/l

    Oocyte donors that present with LH levels < 15UI/I, post trigger by agonists of GnRH

    LH post-trigger > 15 UI/l

    Oocyte donors that present with LH levels > 15UI/I, post trigger by agonists of GnRH

    Outcome Measures

    Primary Outcome Measures

    1. Oocyte retrieval rate [30 days]

      Number of cumulus oocyte complexes (COCs) retrieved divided by the number of follicles > 14mm the day of the last follicular control

    Secondary Outcome Measures

    1. Oocyte maturity rate [30 days]

      Number of metaphase-II mature oocytes retrieved divided by the number of COCs retrieved

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 34 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Oocyte donors included in the oocyte donation program of Clinica EUGIN that have been triggered with GnRH agonists.

    • Any cycle of oocyte donation from the program of Clinica EUGIN, regardless of the type and dose of gonadotropin used for stimulation.

    Exclusion Criteria:
    • None.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinica EUGIN Barcelona Spain 08006

    Sponsors and Collaborators

    • Clínica EUGIN

    Investigators

    • Principal Investigator: Anna Blázquez Ventura, MD, PhD, Clinica EUGIN

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clínica EUGIN
    ClinicalTrials.gov Identifier:
    NCT05109403
    Other Study ID Numbers:
    • AGOTRIG
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Clínica EUGIN

    Study Results

    No Results Posted as of Jul 21, 2022