Ovarian Response in Oocyte Donors Triggered With GnRH Agonists

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

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).

Study Overview

• Status: Completed
• Conditions: Poor Response to Ovulation Induction

• Study Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08006
    • Clinica EUGIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Oocyte donors included in the oocyte donation program of Clinica EUGIN

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oocyte retrieval rate	Number of cumulus oocyte complexes (COCs) retrieved divided by the number of follicles > 14mm the day of the last follicular control	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oocyte maturity rate	Number of metaphase-II mature oocytes retrieved divided by the number of COCs retrieved	30 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: oocyte donation; agonist ovulation trigger
• Other Study ID Numbers: AGOTRIG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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