Follicular Challenge Test to Predict Response to GnRH Agonist Triggering

July 21, 2021 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Tzrifin, Israel
        • Recruiting
        • Shamir Medical Center
        • Contact:
          • Sarit Avraham, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients that undergo fertility preservation

    • patients planned to freeze embryos due to PGT or surrogacy --patients at high risk for OHSS

Exclusion Criteria:

  • Poor ovarian response
  • known hypothalamic- pituitary dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: study group
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.
diagnosis of predictio value

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One treatment cycle (each cycle is 28 days) for each participant (up to 28 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sarit Avraham, Dr, Asaf Harofe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

June 13, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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