Poor Response to Ovulation InductionNCT05109403
Ovarian Response in Oocyte Donors Triggered With GnRH Agonists
An observational study of Poor Response to Ovulation Induction, run by Clínica EUGIN at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Poor Response to Ovulation Induction
- How many people
- 224 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 10 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- No healthy volunteers
- Adult
Study population: Oocyte donors included in the oocyte donation program of Clinica EUGIN
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
- Conditions
- Poor Response to Ovulation Induction
- Keywords
- oocyte donation, agonist ovulation trigger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Oocyte retrieval rate
Number of cumulus oocyte complexes (COCs) retrieved divided by the number of follicles > 14mm the day of the last follicular control
Measured: 30 days
Secondary outcomes (1)
Oocyte maturity rate
Number of metaphase-II mature oocytes retrieved divided by the number of COCs retrieved
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Feb 2021
- Primary completion26 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Poor Response to Ovulation InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica EUGIN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Blázquez Ventura, MD, PhD, Principal investigator, Clinica EUGIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109403
- Sponsor's protocol ID
- AGOTRIG
- Status last verified
- Mar 2023
- First submitted
- 27 Oct 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blazquez A, Falco N, Cano E, Rodriguez F, Vassena R, Miguel-Escalada I, Popovic M, Rodriguez A. No association between LH levels and ovarian response in oocyte donors triggered with gonadotropin-releasing hormone agonist: A prospective study. Eur J Obstet Gynecol Reprod Biol. 2024 Mar;294:163-169. doi: 10.1016/j.ejogrb.2024.01.022. Epub 2024 Jan 18.
PubMed 38266482
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ovarian Response in Oocyte Donors Triggered With GnRH Agonists Depending on the LH Level the Day After the Triggering
- ClinicalTrials.gov ID
- NCT05109403
- Acronym / sponsor ID
- AGOTRIG
- Conditions
- Poor Response to Ovulation Induction
- Keywords
- oocyte donation, agonist ovulation trigger
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Clínica EUGINUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Oocyte donors included in the oocyte donation program of Clinica EUGIN
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Oocyte maturity rate
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 38266482Blazquez A, Falco N, Cano E, Rodriguez F, Vassena R, Miguel-Escalada I, Popovic M, Rodriguez A. No association between LH levels and ovarian response in oocyte donors triggered with gonadotropin-releasing hormone agonist: A prospective study. Eur J Obstet Gynecol Reprod Biol. 2024 Mar;294:163-169. doi: 10.1016/j.ejogrb.2024.01.022. Epub 2024 Jan 18.
- Individual participant dataSharing planned: No
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Poor Response to Ovulation Induction, Infertility, Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Blázquez Ventura, MD, PhD principal investigator
Clinica EUGIN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Response to Ovulation Induction, run by Clínica EUGIN at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte retrieval rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05109403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.