A Comparison of Cost - Effectiveness of Stimulated ICSI and IVM Strategy in PCOS Women

Summary

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.

Conditions

• Infertility

Interventions

OTHER

IVM

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

ICSI

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

Sponsors & Collaborators

• Vietnam National University

  lead OTHER

Principal Investigators

• Khoa D Le, Dr · Mỹ Đức Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

37 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2017-03-31

Completion

2017-04-30