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GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT (GTMLPSGI)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Algeria
Study Type
Interventional
Intervention
Triptorelin 0.1mg
Sponsored by
Centre Hospitalier Universitaire Ibn Rochd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring GnRH agonist, GnRH antagonist, Luteal phase

Eligibility Criteria

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

Inclusion Criteria:

  • Female age < 40 years
  • Baseline FSH and LH < 12 IU/l.
  • Body Mass Index > 18 and < 35 kg/m2
  • No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities
  • Patients with at least one embryo at transfer time

Exclusion Criteria:

  • Very high risk of OHSS (> 30 follicles > 12 mm the day of ovulation triggering).
  • Reduced ovarian reserve
  • Fertilization failure
  • Severe endocrinopathy
  • Azoospermia

Sites / Locations

  • Ibn Rochd Infertility Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GnRH-agonist

Control Arm

Arm Description

Experimental Arm: Triptorelin 0.1 mg

Control Arm: No intervention

Outcomes

Primary Outcome Measures

implantation rate
number of gestational sacs per number of embryos transferred

Secondary Outcome Measures

chemical pregnancy
confirmed by beta-hCG 14 days post embryo transfer
clinical pregnancy
appearance of yolk sac with foetal heart beat at 7 weeks of gestation
live birth
birth of baby beyond 28 weeks of gestation

Full Information

First Posted
January 31, 2014
Last Updated
July 18, 2017
Sponsor
Centre Hospitalier Universitaire Ibn Rochd
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1. Study Identification

Unique Protocol Identification Number
NCT02053779
Brief Title
GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT
Acronym
GTMLPSGI
Official Title
The Impact of a Single Dose of GnRH Agonist (Triptorelin 0,1 mg) at the Time of Implantation on the Reproductive Outcome in IVF Cycles Triggered by a GnRH Agonist Followed by a Small Bolus of HCG the Day of Oocyte Retrieval
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Ibn Rochd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval. Acronyms: GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing GnRH-agonist OPU: ovum pick up NaCl: sodium chloride
Detailed Description
It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU). However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering. Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
GnRH agonist, GnRH antagonist, Luteal phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GnRH-agonist
Arm Type
Experimental
Arm Description
Experimental Arm: Triptorelin 0.1 mg
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Control Arm: No intervention
Intervention Type
Drug
Intervention Name(s)
Triptorelin 0.1mg
Other Intervention Name(s)
Decapeptyl 0.1 mg
Intervention Description
Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg followed by hCG 1500 iu the day of OPU.
Primary Outcome Measure Information:
Title
implantation rate
Description
number of gestational sacs per number of embryos transferred
Time Frame
5 weeks after IVF/ICSI
Secondary Outcome Measure Information:
Title
chemical pregnancy
Description
confirmed by beta-hCG 14 days post embryo transfer
Time Frame
2 weeks after IVF/ICSI
Title
clinical pregnancy
Description
appearance of yolk sac with foetal heart beat at 7 weeks of gestation
Time Frame
5 weeks after IVF/ICSI
Title
live birth
Description
birth of baby beyond 28 weeks of gestation
Time Frame
26 weeks after IVF/ICSI
Other Pre-specified Outcome Measures:
Title
ovarian hyperstimulation syndrome OHSS
Description
frequency of moderate to severe OHSS
Time Frame
from date of triggering until 2 weeks after pregnancy test

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: Female age < 40 years Baseline FSH and LH < 12 IU/l. Body Mass Index > 18 and < 35 kg/m2 No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities Patients with at least one embryo at transfer time Exclusion Criteria: Very high risk of OHSS (> 30 follicles > 12 mm the day of ovulation triggering). Reduced ovarian reserve Fertilization failure Severe endocrinopathy Azoospermia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelhamid benmachiche, Doctor
Organizational Affiliation
Ibn roch infertility centre, cité boussouf, Constantine Algeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ibn Rochd Infertility Centre
City
Constantine
ZIP/Postal Code
25000
Country
Algeria

12. IPD Sharing Statement

Learn more about this trial

GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT

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