Infertility, FemaleNCT04973969
Follicular Challenge Test to Predict Response to GnRH Agonist Triggering
A study testing Decapeptyl in people with Infertility, Female, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
GnRH agonist triggering is used during ART in order to reduce the risk of OHSS. Some studies described that in up to 5% of the cycles triggered with GnRH agonist, a lack of respone or suboptimal response was displayed. Read more about this study
- Who is it for?
- Ages 20 to 41 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Decapeptyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2021to 30 Apr 2022
- Phase
- Interventional
- 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 20 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients that undergo fertility preservation
- patients planned to freeze embryos due to PGT or surrogacy --patients at high risk for OHSS
Who cannot join
- Poor ovarian response
- known hypothalamic- pituitary dysfunction
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shamir medical center
Tzrifin
Sarit Avraham, Dr
About this study
GnRH agonist triggering is used during ART in order to reduce the risk of OHSS. Some studies described that in up to 5% of the cycles triggered with GnRH agonist, a lack of respone or suboptimal response was displayed.
The investigators aim to asses the possibility to predict the respone to ovulation triggering by the response to decapeptyl in the follicular phase of the same cycle.
Read the detailed description
The investigators will use Decapeptyl on day 2 of menstruation followed by antagonist protocol.
Hormonal proflie including E2, P, LH, FSH will be measured. LH surge and the rest of the hormonal profile will be compared to day after ovulation triggering.
- Conditions
- Infertility, Female
- Being tested
- Decapeptyl
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecapeptylOther
diagnosis of predictio value
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | The participants will recieve decapeptyl 0.2 mg on day 2/3 of the follicular phase.At that day, and at the day after, hormonsl profile will be documented. The hormonal profile of the day after follicular decapeptyl administration will be compared to the hormonal profile to test the predictive value. Receives: Other: Decapeptyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response to GnRH triggering
LH levels 10-12 hours after decapeptyl trigger, number of mature oocytes
Measured: One treatment cycle (each cycle is 28 days) for each participant (up to 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jan 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Sarit Avraham, Dr, Principal investigator, Asaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973969
- Sponsor's protocol ID
- 0304-20-ASF
- Status last verified
- Jul 2021
- First submitted
- 13 Jun 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Challenge Test to Predict Response to GnRH Agonist Triggering
- ClinicalTrials.gov ID
- NCT04973969
- Acronym / sponsor ID
- 0304-20-ASF
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 22 Jul 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.
GnRH agonist triggering is used during ART in order to reduce the risk of OHSS. Some studies described that in up to 5% of the cycles triggered with GnRH agonist, a lack of respone or suboptimal response was displayed.
The investigators aim to asses the possibility to predict the respone to ovulation triggering by the response to decapeptyl in the follicular phase of the same cycle.
Detailed description
The investigators will use Decapeptyl on day 2 of menstruation followed by antagonist protocol.
Hormonal proflie including E2, P, LH, FSH will be measured. LH surge and the rest of the hormonal profile will be compared to day after ovulation triggering.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Other: DecapeptylThe participants will recieve decapeptyl 0.2 mg on day 2/3 of the follicular phase.At that day, and at the day after, hormonsl profile will be documented. The hormonal profile of the day after follicular decapeptyl administration will be compared to the hormonal profile to test the predictive value. |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients that undergo fertility preservation
Key exclusion criteria (2 listed)
- Poor ovarian response
- known hypothalamic- pituitary dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decapeptyldiagnosis of predictio value | Other | study group |
Primary outcome
The response to GnRH triggering
Time frame: One treatment cycle (each cycle is 28 days) for each participant (up to 28 days).
LH levels 10-12 hours after decapeptyl trigger, number of mature oocytes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Sarit Avraham, Dr principal investigator
Asaf Harofe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decapeptyl in people with Infertility, Female, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarit Avraham, Dr (00972522371126, sarita@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response to GnRH triggering (time frame: One treatment cycle (each cycle is 28 days) for each participant (up to 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.