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

University Hospital Center Ibn Rochd

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: Triptorelin 0.1 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03039049

02053779

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

GnRH agonist

Experimental group

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

Treatment:

Drug: Triptorelin 0.1 mg

Control

No Intervention group

Description:

No intervention