Infertility
Conditions
Keywords
GnRH agonist, GnRH antagonist, Luteal phase
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.
Interventions
DRUGTriptorelin 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 followed by hCG 1500 iu the day of OPU.
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| implantation rate | 5 weeks after IVF/ICSI | number of gestational sacs per number of embryos transferred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| chemical pregnancy | 2 weeks after IVF/ICSI | confirmed by beta-hCG 14 days post embryo transfer |
| clinical pregnancy | 5 weeks after IVF/ICSI | appearance of yolk sac with foetal heart beat at 7 weeks of gestation |
| live birth | 26 weeks after IVF/ICSI | birth of baby beyond 28 weeks of gestation |
Other
| Measure | Time frame | Description |
|---|---|---|
| ovarian hyperstimulation syndrome OHSS | from date of triggering until 2 weeks after pregnancy test | frequency of moderate to severe OHSS |
Countries
Algeria
Outcome results
None listed