Poor Ovarian Reserve
Conditions
Brief summary
This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in patients with poor ovarian reserve seeking IVF/ICSI treatment.
Detailed description
Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rate
Interventions
DRUGDual trigger
Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once)
DRUGhCG (standard)
human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal uterine cavity (as assessed by hysteroscopy or HSG). * Normal hormonal investigation: TSH, PRL. * Low ovarian reserve patients (AMH\<1.5ng/ml, AFC of 7 or less, 5 oocytes or less retrieved in a previous cycle)
Exclusion criteria
* Abnormal uterine cavity (Hysteroscopy or HSG) * Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of oocytes retrieved (oocyte collection rate) | 38 hrs | the total number of oocytes retrieved divided by the number of follicles aspirated (diameter ≥10 mm) on the day of oocyte retrieval |
| Number of mature oocytes (oocyte maturation rate) | 38 hrs | the ratio of MII oocytes to the number of collected oocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage rate | 12 weeks | the spontaneous loss of a clinical pregnancy occurring before 12 completed weeks of gestational age |
| Fertilization rate | 48 hrs | the ratio of normal fertilized oocytes (2PN) to the number of oocytes used for fertilization |
| Clinical pregnancy rate | 7 weeks | the presence of fetal cardiac activity confirmed by transvaginal ultrasound 7 weeks after embryo transfer |
| Implantation rate | 7 weeks | the number of gestational sacs visualized on ultrasound examination divided by the number of embryos transferred |
Countries
Lebanon
Outcome results
None listed