One of the barriers in patients with diminished ovarian reserve (DOR) is the significantly reduced number of oocytes resulting in fewer oocytes collected and embryos formed. Many ovarian stimulation strategies have been proposed to improve oocyte or embryo quantity which is oocyte accumulation could be a potential option with a comparable success rate and reasonable cost.
Progestin-primed ovarian stimulation (PPOS) protocol could be suggested as an alternative method of premature Luteinizing hormone (LH) prevention in IVF. It favors segment Assisted Reproductive Technology (ART) cycles such as frozen embryo transfer (FET), oocyte donor, fertility preservation, and oocyte accumulation set. The protocol is more patient-friendly and affordable than the GnRH antagonist regimen regarding LH suppression during ovarian stimulation.
Many PPOS protocols have been proposed in which the three most common agents include Dydrogesterone (DYG), Micronised Progesterone (MIP), and Medroxyprogesterone acetate (MPA). Indeed, DYG seems to have some advantages, including oral administration and safety which has been used in the treatment of threatened abortion. Initial evidence of PPOS protocol suggests that oocyte quantity and quality are comparable with other ovarian stimulation regimens. However, data related to the PPOS protocol has not been well documented, including Dydrogesteron-primed ovarian stimulation (DPOS).
There has not been an RCT with a large sample size and well-designed to provide more substantial evidence. A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF is urgently needed.
Woman aged between 18 and 37 years
AFC ≤ 5 and/or AMH ≤ 1.2 ng/ml
Agree to perform freeze-all strategy and single frozen blastocyst embryo transfer
Oocyte recipient
Indication of preimplantation genetic testing
Known allergic reactions to medications in the Study (progesterone products, GnRH antagonist….)
Basal FSH above 15mIU/mL.
Parallel
Dydrogesterone priming ovarian stiumulation protocol
Procedure/SurgeryPatients will be co-administered with oral DYG (Duphaston) 30mg/d and Human Menopausal Gonadotrophin (hMG) 225 IU/day (IU/d) via intramuscular injection from menstrual cycle day 2 - 4 (CD2 - CD4) to the day of final oocyte maturation.
GnRH antagonist protocol
Procedure/SurgeryIn the fixed GnRH antagonist protocol, hMG 225 IU will be administered daily from menstrual cycle day 2 - 4 (CD2 - CD4) and s.c. administration of GnRH antagonist (Ganirelix 0.25 mg) will be initiated daily on the 5th day of stimulation. Treatment with hMG and GnRH antagonist will be continued until the day of final oocyte maturation triggering.
Ongoing pregnancy rate after the first embryo transfer
Ongoing pregnancy is defined as pregnancy with a detectable heart rate at 11 - 12 weeks of gestation after the completion of the first transfer.
Serum LH level
LH levels are measured on day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Serum Estradiol level
Estradiol levels are measured on day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Serum Progesterone level
Progesterone levels are measured on day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection
Premature LH surge
Premature LH surge (PLS) is increased serum LH more than twice the baseline or more than 15 mIU/ml. The rate of Premature LH surge is defined as number of PLS appearances per number of ovarian stimulation cycles
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Tam Anh TP. Ho Chi Minh General Hospital
Lead sponsor
Abbott
Collaborator
