Clinical trial NCT03039049: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: GnRH agonist trigger
IVF
Luteal phase support
Mid-luteal GnRH agonist
Lead sponsor: Centre Hospitalier Universitaire Ibn Rochd
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 328
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: implantation rate
timeFrame: Time Frame: 5 weeks after IVF/ICSI
Secondary outcomes:
measure: positive pregnancy test
timeFrame: Time Frame: 2 weeks after IVF/ICSI
measure: Ongoing pregnancy
timeFrame: Time Frame: 12 weeks after IVF/ICSI
measure: Delivery rate
timeFrame: Time Frame: 26 weeks after IVF/ICSI
measure: Early pregnancy loss
timeFrame: Time Frame: miscarriage before 5 weeks of gestation
Other outcomes:
measure: ovarian hyperstimulation syndrome OHSS
timeFrame: Time Frame: from date of triggering until 2 weeks after pregnancy test]
Locations:
city: Constantine
country: Algeria
facility: Ibnrochd Clinic
city: Constantine
country: Algeria
facility: Ibnrochd IVF center
Study officials:
affiliation: Ibn roch infertility centre, cité boussouf, Constantine Algeria
name: Abdelhamid Benmachiche, M.D
role: PRINCIPAL_INVESTIGATOR
References: