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

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ClinicalTrials.gov Identifier: NCT03005275
Recruitment Status : Withdrawn
First Posted : December 29, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Manh Tuong Ho, Vietnam National University

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.


Condition or disease Intervention/treatment Phase
Infertility Other: IVM Other: ICSI Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Comparison of Cost - Effectiveness of Stimulated ICSI and IVM Strategy in PCOS Women
Study Start Date : January 2017
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
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: 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.


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.

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





Primary Outcome Measures :
  1. live birth [ Time Frame: 36 weeks ]
    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).

  2. direct costs [ Time Frame: 1 year ]
    the costs (Vietnam dong) for medical services, medication, examinations, procedures, etc.

  3. indirect costs [ Time Frame: 1 year ]
    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.).



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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005275


Sponsors and Collaborators
Vietnam National University
Investigators
Principal Investigator: Khoa D Le, Dr Mỹ Đức Hospital

Responsible Party: Manh Tuong Ho, Director, Vietnam National University
ClinicalTrials.gov Identifier: NCT03005275     History of Changes
Other Study ID Numbers: NCKH/CGRH-04-2016
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Deslorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action