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OpenTrials
Completed

NCT Number: NCT05109403

Ovarian Response in Oocyte Donors Triggered With GnRH Agonists

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).

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Key information

Age range

18 year–34 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinica EUGIN

Barcelona, 08006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Oocyte retrieval rate

    Time frame: 30 days

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

Secondary outcomes

  1. Oocyte maturity rate

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Clínica EUGIN

Other

Registry information

Official study title

Comparison of Ovarian Response in Oocyte Donors Triggered With GnRH Agonists Depending on the LH Level the Day After the Triggering

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2021
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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