An interventional study of IVM and ICSI in Infertility, sponsored by Vietnam National University. Withdrawn. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2017-04-18.
Sponsored by Vietnam National University · Not applicable, Interventional, and Other
In polycystic ovary syndrome (PCOS) patients, both in vitro maturation (IVM) and intra-cytoplasmic sperm injection (ICSI) are indicated as optional treatments. Although recently ICSI techniques have been reported as more successful the IVM in achieving pregnancy, they have also become much more expensive for the couples involved. Whilst most high-income countries offer Assisted Reproductive Technology (ART) procedures fully or partially paid by the government, the patients in low or middle-income countries have to cover self-fund infertility treatments. With limited resource, a study conducting based on the prevalence - based cost - effectiveness analysis is necessary for health managers, policy makers and especially to assist patients' decision making in these countries.
However, there are still limited published studies that have evaluated the cost-effectiveness of these strategies are available in the literature. This study is conducted based on the prevalence - based cost - effectiveness analysis from the patient's perspective. Activity - based costing method is used to cost in all levels of the healthcare system, which the patients have to pay directly or indirectly. It also analyses incremental cost - effectiveness to evaluate the cost - effectiveness of IVM and ICSI in PCOS women.
A Cost - Effectiveness Analysis (CEA) Study:
METHODS Cost - Effectiveness Analysis (CEA) Activity - based costing method is used to cost in all levels of the healthcare system which the patients have to pay directly or indirectly for IVM or ICSI. This study also analyzes incremental cost - effectiveness to evaluate the cost - effectiveness of ICSI treatment implemented in PCOS patients.
Sensitivity analysis In this study, two techniques of sensitivity analysis below employing for the decision tree model, which is mentioned as below, are one - way sensitivity analysis and Probabilistic Sensitivity Analysis (PSA).
One - way sensitivity analysis with Tornado diagram will analyses and Probability sensitivity analysis with Monte Carlo simulation and Scatter plots of the difference in costs respecting with the difference in live birth gained will analyses if all parameters varying together simultaneously.
This study also provided the cost - effectiveness acceptability curve (CEAC). The CEAC is applying on the probability sensitivity analysis result, basing on the willingness to pay (WTP). This technique assesses the probability of being cost effective of ICSI treatment comparing to the IVM treatment, respecting to the WTP.
Study Setting: My Duc Hospital Type of data: This study uses a retrospective secondary data collection.
Interventions:
IVM:
ICSI:
Daily SC injections with rFSH - recombinant follicle stimulating hormone (minimum starting dose is around 150 IUI) are started on On day 2 or day 3 of the menstrual cycle (Stimulation Day 1) and continue up to and including Stimulation Day 7.
From Stimulation Day 8 onwards, subjects from ICSI treatment groups will continue with a daily SC dose of rFSH up to the day before Gonadotrophin-releasing hormone (GnRH) agonist day. The maximum rFSH dose to continue treatment after the first 7 days is 300 IU but the dose could be adjusted when desired.
To prevent premature luteinizing hormone (LH) surges the GnRH antagonist (ganirelix acetate SC 0.25 mg/ 0.5 mL) is administered starting on stimulation day 5.
If no follicles ≥ 11mm is visible on the USS on Stimulation day 8, or if no embryo transfer the cycle is to be cancelled. If the ovarian response too high or if there is a risk for Ovarian hyperstimulation syndrome (OHSS), (more than 30 follicles ≥ 11mm on USS), rec-hCG is required to be withheld, and the treatment cycle is to be cancelled.
As soon as three follicles of 17mm are observed by USS at least, a GnRH agonist (Triptorelin 0.2 mg) will be used for final oocyte maturation at the same day. About 34-36 h thereafter, OPU followed by ICSI is performed. Two days after oocyte pick-up 2 fresh embryos will be transferred. Patients with high progesterone level on the trigger day (progesterone level > 2ng/ml), freeze all will be recommended.
Patients using GnRH agonist will have fresh transfer with intense luteal phase support of E2 and P4 (receive intense luteal phase support with E2 and P4 as the same dose mentioned above and progesterone 50 mg i.m. /day), unless patients have high progesterone level on day of trigger (progesterone level > 2ng/ml), freeze all will be recommended.
Frozen embryo transfer cycles:
Time of starting:
Drugs
Adjusting dose:
Decide to transfer:
Drug:
Progesterone per vagina:
Estradiol valerate:
Assessments Before the start of ovarian stimulation, pregnancy is excluded by means of an hCG test, a blood sample is obtained for hormone assessments, and USS is performed to measure and count visible follicles.
Patients will return to the clinic for USS and blood sampling on stimulation days 5 and 8, and the day of hCG or GnRH agonist administration. Additional blood samples will be collected on the day of embryo transfer and 2 weeks after embryo transfer.
Recruitment:
Chief investigator (CI) will review all the medical records and collect all the data (cost, effectiveness, epidemic characteristics...), contacts of PCOS patients. Then CI and colleagues will call the patients for inviting to participate in this project and provide information about the study. If they agree to take part in, collecting data of indirect cost (transportation, administrative costs...) will be provided. The patients have the right to withdraw from the study at any time.
ETHICAL CONSIDERATIONS Institutional Review Board of My Duc Hospital will review the study. The main ethical concerns are whether the research will place the patients at undue risk and whether the subjects are fully informed about the nature of the study. The study will only be conducted after the Ethics Committee approval has been granted.
Ethics approval - From My Duc Hospital Confidentiality - Information sheet de-identified. A unique number is given to each participant. Master list held by CI separately from data.
Declaration of interests - None Access to data - Investigators only Ancillary and post-trial care - None
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Include:
Exclude:
* FSH injection: Day 9, 10 and 11 (can be adjusted 1-3 days before or after to avoid Ultrasound and OPU on holidays). Dose: normally 100 IU/day (maybe 75 - 150 IU/day). * Follicle and endometrium can be evaluated: on the day of final injection or one day later. * hCG 10.000 IU: one day after the final FSH injection, at 9 p.m. Can be adjusted HCG injection day (± 1-2 days) to avoid Ultrasound and OPU on vacation. * OPU: 1,5 day after hCG injection (normally 36-42 hours later). * Sperm collection: on OPU day (if mature follicle presents) or 1 day after OPU day. * Embryo transfer: 3 days after OPU. * Luteal support: progesterone gel (90 mg once daily) intra-vaginally and estradiol (4 mg/day PO, twice daily) initiated on the day of OPU or the day thereafter.
Other: IVM
Daily SC injections with rFSH (minimum starting dose is around 150 IUI) are started on On day 2 or day 3 of the menstrual cycle (Stimulation Day 1) and continue up to and including Stimulation Day 7. From Stimulation Day 8 onwards, subjects from ICSI treatment groups will continue with a daily SC dose of rFSH up to the day before GnRH agonist day. The maximum rFSH dose to continue treatment after the first 7 days is 300 IU but the dose could be adjusted when desired. As soon as three follicles of 17mm are observed by USS at least, a GnRH agonist (Triptorelin 0.2 mg) will be used for final oocyte maturation at the same day. About 34-36 h thereafter, OPU followed by ICSI is performed. Two days after oocyte pick-up 2 fresh embryos will be transferred.
Other: ICSI
FSH injection: Day 9, 10 and 11 (can be adjusted 1-3 days before or after to avoid Ultrasound and OPU on holidays). Dose: normally 100 IU/day (maybe 75 - 150 IU/day). Follicle and endometrium can be evaluated: on the day of final injection or one day later. hCG 10.000 IU: one day after the final FSH injection, at 9 p.m. Can be adjusted HCG injection day (± 1-2 days) to avoid Ultrasound and OPU on vacation. OPU: 1,5 day after hCG injection (normally 36-42 hours later). Sperm collection: on OPU day (if mature follicle presents) or 1 day after OPU day. Embryo transfer: 3 days after OPU. Luteal support: progesterone gel (90 mg once daily) intra-vaginally and estradiol (4 mg/day PO, twice daily) initiated on the day of OPU or the day thereafter.
Daily SC injections with rFSH (minimum starting dose is around 150 IUI) are started on On day 2 or day 3 of the menstrual cycle (Stimulation Day 1) and continue up to and including Stimulation Day 7. From Stimulation Day 8 onwards, subjects from ICSI treatment groups will continue with a daily SC dose of rFSH up to the day before GnRH agonist day. The maximum rFSH dose to continue treatment after the first 7 days is 300 IU but the dose could be adjusted when desired. As soon as three follicles of 17mm are observed by USS at least, a GnRH agonist (Triptorelin 0.2 mg) will be used for final oocyte maturation at the same day. About 34-36 h thereafter, OPU followed by ICSI is performed. Two days after oocyte pick-up 2 fresh embryos will be transferred
live birth
the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life - e.g. beating of the heart, pulsation of the umbilical cord or definite movement of voluntary muscles - whether or not the umbilical cord has been cut or the placenta is attached. Each product of such a birth is considered live born (WHO).
Time frame: 36 weeks
direct costs
the costs (Vietnam dong) for medical services, medication, examinations, procedures, etc.
Time frame: 1 year
indirect costs
the costs (Vietnam dong) for patients' working hour loss (income per one working hour x number of hours), transportation fee (by motorbike, car, bus, taxi, others), accommodation (including hotel, guest house, etc.).
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Vietnam National University