Objective: Comparison of induction and ovulation with clomiphene plus letrozole versus clomiphene plus HMG in clomiphene resistant polycystic ovary syndrome (PCOS). Design Prospective randomized controlled study. Setting: Shahid Akbar Abadi hospital and Royan institute of infertility and a private practice setting. Major inclusion criteria: one year infertility history diagnosed as PCOS and resistant 2-3 cycles to Clomiphene and then 2 cycles to letrozole. Major Exclusion criteria: tubal abnormalities; endocrine problem. Intervention(s): 200 Patients diagnosed PCOS and clomiphene resistant that more over do not respond to letrozole 2.5 mg daily for 5 days for 2 cycles, will be randomly allocated to 2 groups. First group with treat with either Clomiphene plus letrozole therapy (n = 100) and second group with Clomiphene plus HMG therapy (n = 100). Patients in the first group have 100 mg of clomiphene daily starting day 5 of the menses for 7 days plus 5 mg of Letrozole daily starting day 5 of the menses for 5 days (100 patients), and patients in the second group have 100 mg of clomiphene daily starting day 3 of the menses for 5 days plus HMG 150 I.U (100 patients). All patients will be monitored by trans-vaginal ultrasound for the mean follicular volume and thickness of the endometrium on days 10, 12, and 14 of the cycle. Main Outcome Measure(s) Number of growing and mature follicles, occurrence of ovulation, endometrial thickness, occurrence of pregnancy.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015090323621N3
Registration date:2015-12-11, 1394/09/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-11, 1394/09/20
Registrant information
Name
Mahnaz Ashrafi
Name of organization / entity
Iran University Of Medical Sciences, Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 3244
Email address
ashrafi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of induction and ovulation with Clomiphene plus Letrozole versus Clomiphene plus HMG in Clomiphene resistant polycystic ovary syndrome
Public title
Evaluation of effectivness of clomiphene plus Letrozole versus Clomiphene plus HMG in female infertility.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with history of infertility more over than one year and diagnosis of PCOS based on the revised 2003 consensus on diagnostic criteria; By clomiphene resistance that meant failure of ovulation after 100-150 mg CC for 5 days for 2-3 cycles and then resistant to letrozole 2.5 mg daily for 5 days for 2 cycles. Exclusion criteria: Women older than 40 years or younger than 20; fallopian tubes abnormality proved by hysterosalpingography; abnormal semen analysis for their partners according to the modified criteria of the World Health Organization; endocrine problem like hyper or hypo thyroidism, hyperprolactinemia; abnormal karyotype.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Closed Packet
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Siensces, shahid Hemmat highway, Tehran
City
Tehran
Postal code
Iran
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.IUMS.REC.1394.25296
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Ovulation
Timepoint
Day 11 of the menstrual cycle
Method of measurement
Transvaginal ultrasound
2
Description
Pregnancy
Timepoint
After retard of mense
Method of measurement
Pregnancy test by missuring B-hCG
3
Description
The number of follicles
Timepoint
Day 11 of the menstrual cycle
Method of measurement
Transvaginal ultrasound
4
Description
Follicle size
Timepoint
Day 11 of the menstrual cycle
Method of measurement
Transvaginal ultrasound
5
Description
Endometrial thickness
Timepoint
Day 11 of the menstrual cycle
Method of measurement
Transvaginal ultrasound
Secondary outcomes
1
Description
Multiple pregnancies
Timepoint
4-6 weeks after menstural delay
Method of measurement
pregnancy sonography
2
Description
Abortions under 20 weeks
Timepoint
after pegnancy
Method of measurement
pregnancy sonography
Intervention groups
1
Description
Intervention group 1: 100 mg of Clomiphene (Ovumid; Iran Hormone, Tehran, Iran) daily starting day 5 of the menses for 7 days plus 5 mg of Letrozole (Letrozole 2.5 ; SOHA Pharmaceutical Co, Tehran, Iran) daily starting day 5 of the menses for 5 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: 100 mg of Clomiphene (Ovumid; Iran Hormone, Tehran, Iran) daily starting day 3 of the menses for 5 days plus HMG 150 I.U(Merional; IBSA Institute Biochimique SA, CH-6903 Lugano)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi hospitall
Full name of responsible person
Dr Sara Norouzi
Street address
Akbar abadi hospital, Molavi St
City
Tehran
2
Recruitment center
Name of recruitment center
Royan Infertility Institute
Full name of responsible person
Dr Mahnaz Ashrafi
Street address
Royan Infertility Institute, Banihashem square, Ebrahimi St, Sayyad e Shirazi Hwy
City
Tehran
3
Recruitment center
Name of recruitment center
Privite setting clinice
Full name of responsible person
Dr Mahnaz Ashrafi
Street address
Rouyan Alley, Keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran Univercity of Medical Sciences
Full name of responsible person
Dr Seid Ali Javad Mousavi
Street address
Iran Univercity of Medical Sciences, Shahid Hemmat highway, 5th floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran Univercity of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Dr Sara Norouzi
Position
Resident of Obstetrical and Gynocology
Other areas of specialty/work
Street address
Akbar abadi hospital, Molavi St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5563 2277
Fax
Email
sr.norouzi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Univercity of Medical Sciences
Full name of responsible person
Dr. Mahnaz Ashrafi
Position
Associate Professor
Other areas of specialty/work
Street address
Akbar Abadi Hospital, Molavi St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
ashrafim@royaninstitute.org
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)