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Follicular Challenge Test to Predict Response to GnRH Agonist Triggering

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Decapeptyl
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility, Female

Eligibility Criteria

20 Years - 41 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Shamir medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

study group

Arm Description

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.

Outcomes

Primary Outcome Measures

The response to GnRH triggering
LH levels 10-12 hours after decapeptyl trigger, number of mature oocytes

Secondary Outcome Measures

Full Information

First Posted
June 13, 2021
Last Updated
July 21, 2021
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04973969
Brief Title
Follicular Challenge Test to Predict Response to GnRH Agonist Triggering
Official Title
Follicular Challenge Test to Predict Response to GnRH Agonist Triggering
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Decapeptyl
Intervention Description
diagnosis of predictio value
Primary Outcome Measure Information:
Title
The response to GnRH triggering
Description
LH levels 10-12 hours after decapeptyl trigger, number of mature oocytes
Time Frame
One treatment cycle (each cycle is 28 days) for each participant (up to 28 days).

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Infertility patients
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarit Avraham, Dr
Phone
00972522371126
Email
sarita@shamir.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarit Avraham, Dr
Organizational Affiliation
Asaf Harofe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shamir medical center
City
Tzrifin
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarit Avraham, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Follicular Challenge Test to Predict Response to GnRH Agonist Triggering

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