GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Mid-luteal Bolus of GnRHa: a Randomised Controlled Trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 328
- Locations
- 2
- Primary Endpoint
- implantation rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
GnRH agonist
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
Intervention: Triptorelin 0.1 mg (Drug)
Outcomes
Primary Outcomes
implantation rate
Time Frame: Time Frame: 5 weeks after IVF/ICSI
number of gestational sacs per number of embryos transferred
Secondary Outcomes
- positive pregnancy test(Time Frame: 2 weeks after IVF/ICSI)
- Ongoing pregnancy(Time Frame: 12 weeks after IVF/ICSI)
- Delivery rate(Time Frame: 26 weeks after IVF/ICSI)
- Early pregnancy loss(Time Frame: miscarriage before 5 weeks of gestation)
Investigators
benmachiche abdelhamid
Dr benmachiche abdelhamid, private infertility centre, Ibn rochd, constantine, Algeria
Centre Hospitalier Universitaire Ibn Rochd