NCT04973969

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

June 13, 2021

Last Update Submit

July 21, 2021

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • The response to GnRH triggering

    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).

Study Arms (1)

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.

Other: Decapeptyl

Interventions

DecapeptylOTHER

diagnosis of predictio value

study group

Eligibility Criteria

Age20 Years - 41 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInfertility patients
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Poor ovarian response
  • known hypothalamic- pituitary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamir medical center

Tzrifin, Israel

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Sarit Avraham, Dr

    Asaf Harofe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarit Avraham, Dr

CONTACT

00972522371126sarita@shamir.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior physician

Study Record Dates

First Submitted

June 13, 2021

First Posted

July 22, 2021

Study Start

January 1, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)