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Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger

Primary Purpose

Pituitary Downregulation

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Omit Citrotide 0.25 dose on the day of triggering of ovulation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Downregulation focused on measuring GnRH antagonist, Pituitary downregulation, IVF, ICSI

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All antagonist cycle ivf who agree to participate

Exclusion Criteria:

  • expected poor responders.

Sites / Locations

  • Osama AbdalmageedRecruiting
  • Osama AbdalmageedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

-ve arm

+ve arm

Arm Description

The women who do not receive the GnRH antagonist dose on the day of triggering of ovulation (omitted GnRH antagonist arm)

The women who receive the routine dose of GnRH antagonist on the day of triggering of ovulation (the usual protocol)

Outcomes

Primary Outcome Measures

Number of retrieved oocytes
total number and maturation of the retrieved oocytes

Secondary Outcome Measures

Full Information

First Posted
February 1, 2017
Last Updated
February 6, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03044756
Brief Title
Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger
Official Title
Impact of Omitting GnR-antagonist on Ovulation Trigger Day in the Fresh Autologous IVF/ICSI Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Anticipated)
Study Completion Date
December 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

Brief Summary
Omitting the GnRH antagonist on the day of the trigger can be cost effective and more convenient to the women. We will study the impact of omitting the antagonist dose in a prospective randomized trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Downregulation
Keywords
GnRH antagonist, Pituitary downregulation, IVF, ICSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
-ve arm
Arm Type
Experimental
Arm Description
The women who do not receive the GnRH antagonist dose on the day of triggering of ovulation (omitted GnRH antagonist arm)
Arm Title
+ve arm
Arm Type
No Intervention
Arm Description
The women who receive the routine dose of GnRH antagonist on the day of triggering of ovulation (the usual protocol)
Intervention Type
Drug
Intervention Name(s)
Omit Citrotide 0.25 dose on the day of triggering of ovulation
Intervention Description
Omit Citrotide 0.25 dose on the day of triggering of ovulation
Primary Outcome Measure Information:
Title
Number of retrieved oocytes
Description
total number and maturation of the retrieved oocytes
Time Frame
One Month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All antagonist cycle ivf who agree to participate Exclusion Criteria: expected poor responders.
Facility Information:
Facility Name
Osama Abdalmageed
City
Assiut
State/Province
Non-US/Non-Canadian
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama Abdalmageed
Phone
1007972027
Email
drosamast1981@gmail.com
Facility Name
Osama Abdalmageed
City
Assiut
State/Province
Non-US/Non-Canadian
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama Abdalmageed
Email
drosamast1981@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The regulations in Assiut University do not allow protected patient data sharing
Citations:
PubMed Identifier
23875164
Citation
Chang HJ, Lee JR, Jee BC, Suh CS, Lee WD, Kim SH. Cessation of gonadotropin-releasing hormone antagonist on triggering day in flexible multiple-dose protocol: A randomized controlled study. Clin Exp Reprod Med. 2013 Jun;40(2):83-9. doi: 10.5653/cerm.2013.40.2.83. Epub 2013 Jun 30.
Results Reference
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Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger

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