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GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT

Primary Purpose

Infertility

Status

Completed

Phase

Phase 3

Locations

Algeria

Study Type

Interventional

Intervention

Triptorelin 0.1 mg

About this trial

This is an interventional treatment trial for Infertility focused on measuring GnRH agonist trigger, IVF, Luteal phase support, Mid-luteal GnRH agonist

Eligibility Criteria

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

Inclusion Criteria:

Female age < 40 years No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities• Baseline FSH and LH < 12 IU/l.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

Ibnrochd Clinic
Ibnrochd IVF center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GnRH agonist

Control

Arm Description

Drug: Triptorelin 0.1mg Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg. Other Names: • Decapeptyl 0.1 mg

No intervention

Outcomes

Primary Outcome Measures

implantation rate

number of gestational sacs per number of embryos transferred

Secondary Outcome Measures

positive pregnancy test

confirmed by beta-hCG 14 days post embryo transfer

Ongoing pregnancy

presence of foetal heart beat at 12 weeks of gestation

Delivery rate

birth of baby beyond 26 weeks of gestation

Early pregnancy loss

loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy

Full Information

NCT ID

NCT03039049

First Posted

January 30, 2017

Last Updated

July 5, 2017

Sponsor

Centre Hospitalier Universitaire Ibn Rochd

1. Study Identification

Unique Protocol Identification Number

NCT03039049

Brief Title

GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT

Official Title

GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Mid-luteal Bolus of GnRHa: a Randomised Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

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.

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 trigger, IVF, Luteal phase support, Mid-luteal GnRH agonist

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

Drug: Triptorelin 0.1mg Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg. Other Names: • Decapeptyl 0.1 mg

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Drug

Intervention Name(s)

Triptorelin 0.1 mg

Other Intervention Name(s)

Decapeptyl 0.1 mg

Intervention Description

a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.

Primary Outcome Measure Information:

Title

implantation rate

Description

number of gestational sacs per number of embryos transferred

Time Frame

Time Frame: 5 weeks after IVF/ICSI

Secondary Outcome Measure Information:

Title

positive pregnancy test

Description

confirmed by beta-hCG 14 days post embryo transfer

Time Frame

Time Frame: 2 weeks after IVF/ICSI

Title

Ongoing pregnancy

Description

presence of foetal heart beat at 12 weeks of gestation

Time Frame

Time Frame: 12 weeks after IVF/ICSI

Title

Delivery rate

Description

birth of baby beyond 26 weeks of gestation

Time Frame

Time Frame: 26 weeks after IVF/ICSI

Title

Early pregnancy loss

Description

loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy

Time Frame

Time Frame: miscarriage before 5 weeks of gestation

Other Pre-specified Outcome Measures:

Title

ovarian hyperstimulation syndrome OHSS

Description

early and late onset Ovarian hyper stimulation syndrome

Time Frame

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

Eligibility Criteria

Inclusion Criteria: Female age < 40 years No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities• Baseline FSH and LH < 12 IU/l.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, M.D

Organizational Affiliation

Ibn roch infertility centre, cité boussouf, Constantine Algeria

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ibnrochd Clinic

City

Constantine

ZIP/Postal Code

25000

Country

Algeria

Facility Name

Ibnrochd IVF center

City

Constantine

ZIP/Postal Code

25000

Country

Algeria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT

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