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

NCT03005275 | Withdrawn

• 1 other identifier: NCKH/CGRH-04-2016
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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).

  36 weeks

• direct costs

  the costs (Vietnam dong) for medical services, medication, examinations, procedures, etc.

  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.).

  1 year

Study Arms (2)

IVM

OTHER

* 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

ICSI

OTHER

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

Interventions

IVM OTHER

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.

IVM

ICSI OTHER

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

ICSI

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Include: * Couples undergoing IVM or ICSI treatment for the 1st time. * Husband: total mobile sperm count over 10 million/ml (before washing) or over 2 million/ml (after washing) or normal semen analysis (WHO 2010 criteria). * Wife: PCOS patients (Rotterdam European Society of Human Reproduction and Embryology (ESHRE)/ American Society of Reproductive Medicine (ASRM) 2004 aged from 18 to 37 at the time of conducting IVM or ICSI. * Each subject must have results of clinical laboratory test (complete blood count (CBC), blood chemistries, and urinalysis, pap smear) within normal limits or clinically acceptable to the investigator, as measured by the local laboratory at screening. * Each subject must have results of a physical examination, including blood pressure, within normal limits or clinically acceptable limits to the investigator. Exclude: * The subject (wife) has a recent (i.e. within 3 years prior to conducting IVM or ICSI) history of/ or any current endocrine abnormality (irrespective whether the patient is stabilized on treatment). * The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment. * Endometriosis (in uterine muscle, ovary or pelvis) or IVF/ICSI with donated sperm, donated eggs or IVM with donated sperm, clomiphene citrate resistant PCOS (PCOS), tubal factor (blocked fallopian tube, hydrosalpinx), abnormal uterine structure (submucosal fibroid or intramural fibroid ≥30 mm, uterine polyp, bicornuate uterus, didelphic uterus). * The subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by the local laboratory; results obtained within one year prior to conducting IVM or ICSI are considered valid). * The subject has contraindications for the use of gonadotropins (ex; tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, or ovarian cysts) or GnRH-antagonist (e.g. hypersensitivity, pregnancy/lactation). * The subject has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indications or for the health of the offspring. * The subject smokes or has recently stopped smoking (ex. within the last 3 months). * The subject has a history or presence of alcohol or drug abuse within 12 months prior to conduct IVM or ICSI. * The subject has used any experimental drugs within 3 months prior to conduct IVM or ICSI. * The subject is participating in any other clinical study (excluding surveys). * Those who do not complete the process of IVM or IVF/ICSI (withdrawing, no embryo for transfer or embryos haven't been transferred).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vietnam National University: lead

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Khoa D Le, Dr

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share