In this study, 50 Women aged 20-35 years with PCOS normal ovarian reserve and randomly checked. If the patient have received clomiphene citrate (150-100) and gonadotropin, but the dominant follicle Not formed will be studied and if the patient is allergic to L-Carnitine, not wanting , family history of infertility, If have heart disease and lung be excluded. The research method in this case is In IUI cycles The induction of ovulation with clomiphene citrate (100-150 mg) and gonadotropin injections (3-5 pieces) is done L - carnitine from day 3 starting clomiphene citrate every 12 hours 2 vials (each vial, 1 g). until hcg injections, that Coincide with the sighting of a dominant follicle will be added to the diet, and Number of dominant follicles and endometrial thickness will be recorded and 36 hours after injection HCG, IUI Will be doing. Luteal phase support with progesterone products will be done. Treatment Outcome included number of Dominant follicles and pregnancy achievement Before and after receipt of L- carnitine in patients will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030213566N2
Registration date:2014-04-23, 1393/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-23, 1393/02/03
Registrant information
Name
Kobra Hamdi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
hamdik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of addition of L –Carnitine in Polycystic Ovary Syndrome (PCOS) Patients With Resistant Clomiphene Citrate and Gonodotropin Treatment
Public title
Effect of addition of L –Carnitine in Polycystic Ovary Syndrome (PCOS) Patients With Resistant Clomiphene Citrate and Gonodotropin Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Encloses Criteria: Patients with infertility resistant to clomiphene citrate and gonadotropin regimens in age from 20-35 years with normal FSH and LH and AMH and estradiol
Exclusion criteria:patient is allergic to L-Carnitine, not wanting , family history of infertility, If have heart disease and lung
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
vice chancellor of research, Tabriz University of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2013-03-18, 1391/12/28
Ethics committee reference number
91225
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Growth of the dominant follicle
Timepoint
The first 15 day menstrual cycle
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Achieving pregnancy
Timepoint
16 days after injection of Hcg
Method of measurement
Blood tests
Intervention groups
1
Description
L - carnitine from day 3 starting clomiphene citrate every 12 hours 2 vials (each vial, 1 g)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Kobra Hamdi
Street address
Alzahra Hospital, bagh-shomal; Artesh Street South
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, Tabriz University of Medical
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Tabriz University of Medical
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Kobra Hamdi
Position
Gynecologist, Fellowship of Infertility
Other areas of specialty/work
Street address
Alzahra Hospital, Bagh-shomal; Artesh Street South