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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Triptorelin 0.1 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH agonist<br>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 | Drug: Triptorelin 0.1 mg<br>* a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.<br>* Other names: Decapeptyl 0.1 mg;|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | number of gestational sacs per number of embryos transferred | Time Frame: 5 weeks after IVF/ICSI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive pregnancy test | confirmed by beta-hCG 14 days post embryo transfer | Time Frame: 2 weeks after IVF/ICSI | 
| Ongoing pregnancy | presence of foetal heart beat at 12 weeks of gestation | Time Frame: 12 weeks after IVF/ICSI | 
| Delivery rate | birth of baby beyond 26 weeks of gestation | Time Frame: 26 weeks after IVF/ICSI | 
| Early pregnancy loss | loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy | Time Frame: miscarriage before 5 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRH agonist trigger, IVF, Luteal phase support, Mid-luteal GnRH agonist