Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Screening for eligibility and randomization
Ovarian stimulation
Oocytes retrieval and cryopreservation
Oocyte thawing and ICSI
Embryo cryopreservation
Endometrium preparation and embryo transfer
Pregnancy test and ultrasound to confirm fetal viability
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DPOS protocol | Active Comparator | Women will receive oral Dydrogesterone 10mg (Duphaston 10mg) t.i.d daily from the first day of ovarian stimulation till the day of final oocyte maturation. |
|
| GnRH antagonist protocol | Placebo Comparator | Women will receive GnRH antagonist (Ganirelix 0.25mg) once subcutaneously daily from day 5 of ovarian stimulation till the day of final oocyte maturation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone priming ovarian stiumulation protocol | Procedure | Patients 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 11 - 12 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | On day 1, day 5, day 8 of FSH administration, on the trigger day and 12 hours after the trigger injection |
| Serum Estradiol level |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nhu H Giang, MD., MCE | Contact | +84 793 231 721 | nhugh@tahospital.vn | |
| Loc M T Nguyen, MSc | Contact | +84 39 2045478 | locnmt@tahospital.vn |
| Name | Affiliation | Role |
|---|---|---|
| Nhu H Giang, MD., MCE | Tam Anh TP. Ho Chi Minh General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVFTA | Recruiting | Hanoi | Hanoi | 100000 | Vietnam |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2024 | Nov 6, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| GnRH antagonist protocol | Procedure | In 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. |
|
|
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 |
| 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 | 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 | on the day of trigger, an average of 2 weeks after FSH administration |
| Duration of ovarian stimulation | Number of ovarian stimulation days | From the day 1 of FSH administration to the day of trigger, an average of 2 weeks after FSH administration |
| Total dose of FSH | A number of international units of FSH are administrated during an ovarian stimulation cycle | From the day 1 of FSH administration to the day of trigger, an average of 2 weeks after FSH administration |
| Number of Cumulus-oocyte complex | Number of Cumulus-oocyte complexes after oocyte retrieval | On the oocyte retrieval day, an average of 2 weeks after FSH administration |
| Number of MII oocyte | Number of MII oocytes after denuding | On the oocyte retrieval day, an average of 2 weeks after FSH administration |
| Number of survival oocyte | Number of survival oocytes after thawing | On the oocyte retrieval day of the ovarian stimulation cycle for ICSI, an average of 2 weeks after FSH administration |
| Fertilization rate per oocyte inseminated/injected | Fertilization is defined as the appearance of two PN at 17±1 hour per inseminated/injected | On the oocyte retrieval day of the ovarian stimulation cycle for ICSI, an average of 2 weeks after FSH administration |
| Embryo-cleavage rate | Number of embryos on Day 3 after ICSI day | Day 3 after ICSI day |
| Blastocyst rate | Numbers of embryos on Day 5 and Day 6 after ICSI | Day 5 and Day 6 after ICSI day |
| Number of survival blastocyst | Number of survival embryos on Day 5 and Day 6 after thawing | Day 5 and Day 6 after ICSI day |
| Top-quality blastocyst rate | Numbers of embryos on Day 5 and Day 6 with good quality after ICSI | Day 5 and Day 6 after ICSI day |
| Positive pregnancy test | A positive pregnancy test is defined as a serum hCG level greater than 25 mIU/mL 11 days after the first transfer | 11 days after the first transfer |
| Implantation rate | Implantation rate is defined as the number of gestational sacs per number of embryos transferred 3 weeks after the first transfer | Within 12 weeks of gestation |
| Biochemical pregnancy | Biochemical pregnancy is defined as a pregnancy diagnosed only by the detection of beta hCG in serum or urine | Within 12 weeks of gestation |
| Miscarriage | Complete loss of clinical pregnancy at 12 weeks of gestation | Within 12 weeks of gestation |
| Multiple pregnancy rate | Multiple pregnancy rate is explained as two or more gestational sacs or positive heartbeats by transvaginal sonography 5 weeks after embryo placement | Within 12 weeks of gestation |
| Ectopic pregnancy rate | Ectopic pregnancy confirmed by sonography or laparoscopy at 12 weeks of gestation | Within 12 weeks of gestation |
| Adverse events | Adverse events regarding medications according to local information products | Through study completion of each individual patient, an average of 6 months |
| Drop-out | Drop-out is defined as any patient discontinuing the Study or the investigator withdrawing them from the Study for any reason. | Through study completion, approximately within 2 years |
| Quality of life score | Quality of life is assessed by Vietnamese WHO-BRIFE questionnaire | On day 1 of FSH administration of the first ovarian stimulation cycle for oocyte vitrification and on the trigger day of the ovarian stimulation cycle for ICSI |
| Ivfta Hcmc | Recruiting | Ho Chi Minh City | Ho Chi Minh | 70000 | Vietnam |
|
| Prot_001.pdf |