Infertility
Conditions
Keywords
GnRH agonist trigger, IVF, Luteal phase support, Mid-luteal GnRH agonist
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.
Interventions
a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.
Sponsors
Centre Hospitalier Universitaire Ibn Rochd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| implantation rate | Time Frame: 5 weeks after IVF/ICSI | number of gestational sacs per number of embryos transferred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery rate | Time Frame: 26 weeks after IVF/ICSI | birth of baby beyond 26 weeks of gestation |
| positive pregnancy test | Time Frame: 2 weeks after IVF/ICSI | confirmed by beta-hCG 14 days post embryo transfer |
| Ongoing pregnancy | Time Frame: 12 weeks after IVF/ICSI | presence of foetal heart beat at 12 weeks of gestation |
| Early pregnancy loss | Time Frame: miscarriage before 5 weeks of gestation | loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy |
Other
| Measure | Time frame | Description |
|---|---|---|
| ovarian hyperstimulation syndrome OHSS | Time Frame: from date of triggering until 2 weeks after pregnancy test] | early and late onset Ovarian hyper stimulation syndrome |
Countries
Algeria
Outcome results
None listed