Clinical trial NCT02053779: GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: GnRH agonist
GnRH antagonist
Luteal phase
Lead sponsor: Centre Hospitalier Universitaire Ibn Rochd
Sponsor class: OTHER
First posted: 2014-02-04
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.

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.

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

Primary outcomes:
measure: implantation rate
timeFrame: 5 weeks after IVF/ICSI
Secondary outcomes:
measure: chemical pregnancy
timeFrame: 2 weeks after IVF/ICSI
measure: clinical pregnancy
timeFrame: 5 weeks after IVF/ICSI
measure: live birth
timeFrame: 26 weeks after IVF/ICSI
Other outcomes:
measure: ovarian hyperstimulation syndrome OHSS
timeFrame: from date of triggering until 2 weeks after pregnancy test
Locations:
city: Constantine
country: Algeria
facility: Ibn Rochd Infertility Centre
Study officials:
affiliation: Ibn roch infertility centre, cité boussouf, Constantine Algeria
name: Abdelhamid benmachiche, Doctor
role: PRINCIPAL_INVESTIGATOR
References: