Evaluation of the effect of adding L-carnitine to ovulation stimulation treatment of clomiphene-resistant PCOD women on ovulation and pregnancy
Design
Clinical trial with control group, with parallel groups, triple-blind, randomized, phase 2 on 148 patients. To randomize,
Balanced Block Randomization method was used.
Settings and conduct
The effect of L-carnitine addition to ovulation stimulation treatment of clomiphene-resistant PCOD women on ovulation and pregnancy. Location of infertility clinic of Imam Hossein Hospital in Tehran. The researcher, patient, nurse, and data analyzer were blinded to the type of group the patient was in. 148 patients of Iranian infertile women with clomiphene-resistant PCOD were divided into control and intervention groups by random allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosed as PCOS; hysterosalpingo-graphy (HSG) normal; semen analysis normal spouse.
Exclusion criteria: the patient's unwillingness to continue the study; other pathology of the uterus and ovaries; tube infertility diagnosed with hysterosalpingogram (HSG).
Intervention groups
Patients who have received clomiphene for three months and have not become pregnant will be randomly divided into two groups. The first group will be re-induced with clomiphene three months later and the second group will be treated with L-carnitine (capsule) in addition to clomiphene.
Main outcome variables
Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050980N1
Registration date:2021-05-02, 1400/02/12
Registration timing:prospective
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Minoo Hashemzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9770
Email address
minoohashemzadeh9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of adding L-carnitine to clomiphene resistant PCOS women on the ovulation and the pregnancy rate
Public title
Evaluation of the effect of adding L-carnitine to the treatment of ovulation stimulation in women with polycystic ovaries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
PCOS
Normal Hysterosalpingo-graphy (HSG)
Normal Semen analysis
Exclusion criteria:
The patient's unwillingness to continue the study
Other pathology of the uterus and ovaries
Tubal infertility diagnosed with Hysterosalpingogram (HSG)
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random: in this method, first the list of names of all patients will be obtained, then a number will be assigned to each of them and the required number will be selected using a table of random numbers.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the patient will not be aware of the type of study group in which she is placed, nor will the researcher, patient care nurse, and data analyzer be aware of the type of patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Bldg No.2, SBUMS, Arabi Ave., Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.SBMU.MSP.REC.1398.272
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
At the beginning of the study and after the end of the study
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: patients who received clomiphene for three months and were not pregnant and will be re-induced with clomiphene three months later.
Category
Placebo
2
Description
Intervention group: patients who have been receiving clomiphene for three months and have not become pregnant will be treated with L-carnitine (capsule) in addition to clomiphene.