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The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

Primary Purpose

Sterility, Infertility

Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Triptorelin
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sterility focused on measuring GnRH agonist, In Vitro fertilization, Assisted Reproductive Technology, Follicule Maturation, Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Normal uterine cavity (as assessed by hysteroscopy or HSG).
  • Normal hormonal investigation: TSH, PRL.
  • More than 15 follicles (≥12 mm in diameter) on ultrasound, and/or estradiol level of > 3500 pg/ml on the day of trigger.

Exclusion Criteria:

  • History of three or more miscarriages.
  • History of three or more previous IVF failures.
  • Abnormal uterine cavity (Hysteroscopy or HSG).

Sites / Locations

  • American University of Beirut Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Repeated 3-dose GnRHa " Triptorelin"

Conventional 1-dose GnRHa " Triptorelin"

Arm Description

Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart (0.3/0.2/0.2mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.

Triptorelin pre-filled syringes will be administered subcutaneously in a single dose (0.3 mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles

Secondary Outcome Measures

Oocyte collection rate
oocyte maturation rate ovarian volume on the day of hCG titer

Full Information

First Posted
May 25, 2017
Last Updated
July 19, 2023
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03169166
Brief Title
The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies
Official Title
The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective comparative randomized controlled trial investigating the effect of two GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology.
Detailed Description
Follicle maturation triggering is the final differentiation process of an immature egg before fertilization, either in normal or stimulated ovarian cycles in assisted reproductive techniques. This step has traditionally been accomplished by the administration of human chorionic gonadotropin (hCG) trigger which mimics LH activity. However, hCG is a primary cause of severe ovarian hyperstimulation syndrome (OHSS) in women and appears to initiate the complex cascade that leads to the development of serious medical complications. Numerous strategies have been suggested to prevent OHSS; one of these is the administration of a gonadotropin releasing hormone (GnRH) agonist trigger instead of hCG. Despite a high safety profile, the GnRH agonist trigger of follicle maturation was found to be associated with a decreased probability of clinical and ongoing pregnancy rates and very high miscarriage rates. A profoundly deficient luteal phase is believed to be the cause of compromised reproductive outcome. Our personal clinical practice at the AUBMC Fertility Center seems to indicate that a novel GnRH agonist administration protocol is associated with a comparable reproductive performance to standard hCG trigger. In this study, we aim to validate the above clinical impression and assess associated parameters of success. Therefore, a prospective comparative randomized controlled trial will be performed in order to investigate the effect of three repeated doses of GnRH agonist trigger "Triptorelin" accompanied by intensive Luteal Support on the ongoing pregnancy outcome in women who are hyper-responders to ovarian stimulation when undergoing assisted reproductive technology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility, Infertility
Keywords
GnRH agonist, In Vitro fertilization, Assisted Reproductive Technology, Follicule Maturation, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repeated 3-dose GnRHa " Triptorelin"
Arm Type
Experimental
Arm Description
Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart (0.3/0.2/0.2mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.
Arm Title
Conventional 1-dose GnRHa " Triptorelin"
Arm Type
No Intervention
Arm Description
Triptorelin pre-filled syringes will be administered subcutaneously in a single dose (0.3 mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Other Intervention Name(s)
Gonapeptyl
Intervention Description
Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles
Time Frame
20 weeks from Last Menstrual Period (LMP)
Secondary Outcome Measure Information:
Title
Oocyte collection rate
Description
oocyte maturation rate ovarian volume on the day of hCG titer
Time Frame
On the day of ovum pick-up
Other Pre-specified Outcome Measures:
Title
Fertilization rate
Time Frame
16-18 hours post insemination
Title
Total pregnancy rate
Time Frame
10-12 days from embryo transfer
Title
Clinical pregnancy rate
Time Frame
7 weeks from LMP
Title
Implantation rate
Time Frame
7 weeks from LMP
Title
Miscarriage rate
Time Frame
From a positive pregnancy test till 20 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Normal uterine cavity (as assessed by hysteroscopy or HSG). Normal hormonal investigation: TSH, PRL. More than 15 follicles (≥12 mm in diameter) on ultrasound, and/or estradiol level of > 3500 pg/ml on the day of trigger. Exclusion Criteria: History of three or more miscarriages. History of three or more previous IVF failures. Abnormal uterine cavity (Hysteroscopy or HSG).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnny Awwad, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

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