The purpose of this study is to compare the effectiveness of low dose human chorionic gonadotropin (HCG) in combination with Clomiphene citrate to induce ovulation and its endocrine response in patients who had previously failed to ovulate on single Clomiphene citrate therapy. We will also compare the effectiveness and endocrine response of this approach with the regimen of adding HMG to Clomiphene citrate. Infertile women with PCOS, who have shown resistance to Clomiphene Citrate (150 mg- 5 days) in a previous IUI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will be enrolled in this prospective randomized clinical trial study and will be randomly divided into three groups. Control group will receive 100 mg Clomiphene citrate on days 3 to 7 of cycle and 150 mg human menopausal gonadotropin (HMG) during days 7, 8, and 9. An intervention group will receive 100 mg Clomiphene citrate plus 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter. Another intervention group (Group C) will receive 100 mg dose of Clomiphene citrate plus 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9 (without attention to follicle size). In both experimental groups HCG administration will be continued until the largest follicle is 18-20 mm. Primary outcome measures will be OHSS rate, and multiple pregnancy rate. Other outcome measures are cancellation rate, implantation rate, abortion rate, pregnancy rate, and endometrial status.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805061141N3
Registration date:2009-11-14, 1388/08/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-11-14, 1388/08/23
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute Research Centre
Expected recruitment start date
2009-06-01, 1388/03/11
Expected recruitment end date
2011-04-01, 1390/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of micro-dose human chorionic gonadotropin (hCG) with HMG in PCOS patients with previous Clomiphene Citrate (CC)-resistant anovulation
Public title
Micro dose HCG in PCOS patients with previous Clomiphene Citrate (CC)-resistant anovulation
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 30 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT00947713
Registration date
2009-07-27, 1388/05/05
Ethics committees
1
Ethics committee
Name of ethics committee
Reproductive Medicine Research Center, Royan Institute, ACECR
Street address
Banihashem square, Eastern Hafez Avenue.
City
Tehran
Postal code
Approval date
1388-06-24, 769/01/-633
Ethics committee reference number
EC/88/1040
Health conditions studied
1
Description of health condition studied
PCOS patients with clomid failure
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
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
2
Description
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 outcomes
1
Description
clinical Pregnancy rate
Timepoint
one to ten days after positive serum BHCG
Method of measurement
sonography and observation of gestational sac
2
Description
Implantation rate
Timepoint
1 to 10 days after positive BHCG
Method of measurement
ratio between observed gestational sac and total number of embryo transfered
3
Description
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
4
Description
Miscarriage rate
Timepoint
during first 12 weeks after pregnancy
Method of measurement
clinical symptoms and sonographic criteria
5
Description
Endometer stage
Timepoint
at day 9 of cycle, and repeat every 48 hours
Method of measurement
sonography
Intervention groups
1
Description
100 mg Clomiphene citrate on days 3 to 7 of cycle and 150 mg human menopausal gonadotropin (HMG) during days 7, 8, and 9
Category
Treatment - Drugs
2
Description
100 mg Clomiphene citrate plus 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter
Category
Treatment - Drugs
3
Description
100 mg Clomiphene citrate plus 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9 (without attention to follicle size)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Reproductive Medicine Research Center, Royan Institute, ACECR
Full name of responsible person
Fatemeh Rastegar
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reproductive Medicine Research Center, Royan Institute, ACECR
Full name of responsible person
Dr. Ahmad Vosoogh
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat Highway,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reproductive Medicine Research Center, Royan Institute, ACECR
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Reproductive Medicine Research Center, Royan Institute, ACECR
Full name of responsible person
Dr. Mahnaz Ashrafi
Position
Head of Endocrinology and Female Infertility Department, Royan Institute/ Gynecologyst
Other areas of specialty/work
Street address
Banihashem square, Eastern Hafez Avenue
City
Tehran
Postal code
Phone
+98 21 2356 2000
Fax
Email
ashrafim@royaninstitute.org
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reproductive Medicine Research Center, Royan Institute, ACECR
Full name of responsible person
Dr. Mahnaz Ashrafi
Position
Head of Endocrinology and Female Infertility Department, Royan Institute/ gynecologyst
Other areas of specialty/work
Street address
Banihashem squrae, Eastern Hafez Street
City
Tehran
Postal code
Phone
+98 21 2356 2000
Fax
Email
ashrafim@royaninstitute.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Medicine Research Center, Royan Institute, ACECR
Full name of responsible person
Kiandokht Kiani
Position
Researcher/ Master of Science on Midwifery
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
kiani.kiandokht@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)