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Micro dose HCG in PCOS patients with previous Clomiphene Citrate (CC)-resistant anovulatio

Phase 1
Completed
Conditions
PCOS patients with clomid failure.
Polycystic ovarian syndrome
Registration Number
IRCT138805061141N3
Lead Sponsor
Reproductive Medicine Research Center, Royan Institute, ACECR
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
250
Inclusion Criteria

age under 30 years, primary infertility, PCOS diagnosed by the Rotterdam criteria, by two of the following three features: 1) oligo or anovulation, 2) clinical and/or biochemical signs of hyper androgenism, or 3) polycystic ovaries, previously documented dominant follicle or follicles (R12 mm mean diameter) on transvaginal Ultrasound follicular monitoring, Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy, normal fasting glucose and insulin levels, normal serum prolactin, and thyroid stimulating hormone, Estradiol, Progesterone, FSH and dehydroepiandrosterone sulfate levels, normal semen analysis by World Health Organization criteria

Exclusion Criteria

previous history of IVF or ICSI treatments, history of hormonal treatment within three month prior to admission (Except OCP, progesterone), history of ovarian cutter or Ovarian drilling, BMI higher than 30, presence of ovarian cyst (more than 30 mm) during third cycle ultrasound

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Multiple pregnancy rates. Timepoint: one to 10 days after pregnancy test and after BHCG more than 1000. Method of measurement: observation of gestational sac with fetal heart rate by sonography.;Ovarian hyperstimulation syndrom. Timepoint: at ovum puncture day, at embryo transfer day and three days after embryo transfer. Method of measurement: clinical symptoms, follicle numbers by sonography, serum estradiol level.
Secondary Outcome Measures
NameTimeMethod
Clinical Pregnancy rate. Timepoint: one to ten days after positive serum BHCG. Method of measurement: sonography and observation of gestational sac.;Implantation rate. Timepoint: 1 to 10 days after positive BHCG. Method of measurement: ratio between observed gestational sac and total number of embryo transfered.;Cancellation rate. Timepoint: after ovarian stimulation, after insemination in lab, after embryo transfer. Method of measurement: lack of follicle or oocyte by sonography, lack of embryo in lab, and OHSS.;Miscarriage rate. Timepoint: during first 12 weeks after pregnancy. Method of measurement: clinical symptoms and sonographic criteria.;Endometer stage. Timepoint: at day 9 of cycle, and repeat every 48 hours. Method of measurement: sonography.
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