Ovarian Stimulation, Human Chorionic Gonadotropin, Oocyte Donors
Conditions
Keywords
GnRH agonist, Dual trigger, Oocyte Donors
Brief summary
The goal of this clinical trial is to compare GnRH-agonist trigger with dual GnRH-agonist and HCG trigger in oocyte donors. The main questions it aims to answer are: * Maturation rate (Metaphase II/ Total number of COCs collected) * Fertilization rate * Embryo quality day 3 * Fragmentation rate embryo day 3 * Blastulation rate (Day5/6/7) * Quality of blastocyst (Gardner criteria) Participants will undergo controlled ovarian stimulation with a GnRH antagonist protocol Researchers will compare the effects of final maturation with GnRH-agonist trigger to a dual trigger (hCG and GnRH-a)
Detailed description
Final oocyte maturation is a critical step in the process of the Assisted Reproductive Technology (ART) treatment and has a certain impact on oocyte yield and oocyte competency. There are three different types of trigger: hCG, GnRH-agonist or dual trigger (hCG and GnRH-agonist combined), and the choice depends on the ovarian stimulation protocol, the ovarian response and on the clinical standard of the IVF clinic. As oocyte donors are at high risk for OHSS, a GnRH-agonist trigger (GnRH-a) is the most commonly used modality for triggering final maturation. However, a certain number of oocyte donors may have a suboptimal response to GnRH-a trigger only, with a yield of oocytes less than the 10th percentile, with a clear negative impact on oocyte efficiency and competency. This study aims to evaluate whether oocyte competence can be improved in oocyte donors with a previously suboptimal response to GnRH-a, by using a dual trigger in a subsequent ovarian stimulation cycle, in which hCG is added to the GnRH-agonist for final maturation
Interventions
Human chorionic gonadotropin will be added to GnRH-agonist as a dual trigger in participants previously having had a suboptimal response to GnRH-agonist trigger only
DRUGGnRH-agonist only trigger
GnRH-agonist only will be used for final maturation
Sponsors
ART Fertility Clinics LLC
Embryolab Fertility Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI: 18 - 25 * AMH: 1-3ng/ml * AFC: 15 * Peak E2 in previous ovarian stimulation cycle: \< 4000 pg/ml * Ovarian response in first stimulation cycle: \< 20 follicles over 10mm in total, at time of triggering * Peak E2 in study cycle: \< 4000 pg/ml * Suboptimal response to trigger medication at first stimulation cycle * Male age \< 50 years old with normospermia
Exclusion criteria
* Oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (OHSS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte maturation rate | 18 months prospective trial | Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day |
| Fertilization rate | 18 months prospective trial | number of 2PN embryos per total number of MII oocytes fertilised |
| Blastulation rate | 18 months prospective trial | Number of blastocysts up to day 6 per number of fertilised 2PN embryos |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of recipients per donor cycle | 18 months prospective trial | The number of recipients matched per donor |
| Ongoing Pregnancy Rate | 28 months prospective trial | number of pregnancies with positive fetal heart per number of embryotransfers performed |
| Live Birth Rate | 28 months prospective trial | number of live births per number of embryotransfers performed |
Countries
Greece
Outcome results
None listed