Ovarian Response in Oocyte Donors Triggered With GnRH Agonists

Poor Response to Ovulation Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109403
• Other study ID #: AGOTRIG
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: March 2023
• Source: Clínica EUGIN
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: February 10, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Poor Response to Ovulation Induction

Locations

Country	Name	City	State
Spain	Clinica EUGIN	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Clínica EUGIN

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oocyte maturity rate	Number of metaphase-II mature oocytes retrieved divided by the number of COCs retrieved	30 days