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Comparison of adding Tamoxifen or Gonadotropin to Clomiphene for induction ovulation in Polycystic Ovary Syndrome (PCOS) patients resistance to Clomiphene

Protocol summary

Summary
Clomiphen citrate (CC) is used as first line treatment in PCOS patients but Patient may resistant to CC up to 25% and its pregnancy rate is 40%. One of the causes of low pregnancy rate by CC related to its possible antiestrogenic effect on endometer. Tomoxiphen(Tom) is a similar drug which has less antiestegenic effect on endometer and cervical mucous. Also, ovulation induction with Gonadotropin is successful in these patients but it is expensive and extensive monitoring that is necessary because of the high sensitivity of polycystic ovaries to exogenous gonadotropin, with a high risk of ovarian hyperstimulation(OHSS), cycle termination, multiple pregnancy, and abortion. Aim: The aim of this study is the comparison of adding Tomoxiphen or gonaditropin to CC in cc-resistant PCOS patients to improve ovulation. Inclusion citeria: PCOS CC resistance Patients with age between 18 and 35 years,.. Exclusion criteria: hyperprolactinaemia, hypercorticism or thyroidism, pelvic pathology or surgery, ... Materials and Methods: This double-blind randomized controlled trial study was performed on 200 infertile PCOS patients that referred to Fatemeh-Zahra Infertility and Reproductive Health Research Center from 2010 to 2011. In addition to the CC (100 mg/day) from day 3 to day 9 of the cycle day, each patient was selected randomly to receive either Tom; 20mg/day (group I), or Gonadotropin HMG; 75mg/day in cycle day 7, 8, 9. (group II). Outcome: Rate of ovulation, pregnancy, dominant follicle, and endometrial thickness are compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904121760N8
Registration date: 2010-11-04, 1389/08/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-11-04, 1389/08/13
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of adding Tamoxifen or Gonadotropin to Clomiphene for induction ovulation in Polycystic Ovary Syndrome (PCOS) patients resistance to Clomiphene
Public title
Comparison of adding Tamoxifen or Gonadotropin to Clomiphene for induction ovulation in Polycystic Ovary Syndrome (PCOS) patients resistance to Clomiphene
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PCOS Clomiphen citrate resistance Patients with age between 18 and 35 years, years period of infertility between 1.5-5 yr and BMI between 19-35. Exclusion criteria: hyperprolactinaemia, hypercorticism or thyroidism, pelvic pathology or surgery, infertility factor other than anovulation excluded.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical sciences
Street address
Gangafroz Avenue, Babol University of Medical sciences
City
Babol
Postal code
Approval date
2010-09-13, 1389/06/22
Ethics committee reference number
1021

Health conditions studied

1

Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic Ovary Syndrome

Primary outcomes

1

Description
Dominant follicle
Timepoint
12 -16 menstrual cycle
Method of measurement
sonography

2

Description
Rate ovulation
Timepoint
36-38 days after HCG injection
Method of measurement
sonography

3

Description
Endometrial thickness
Timepoint
at HCG injection day
Method of measurement
sonography

Secondary outcomes

1

Description
Occurrence of pregnancy
Timepoint
25 days after HCG injection
Method of measurement
sonography

Intervention groups

1

Description
Intervention Group: Clomiphene Citrate (150mg) plus Tamoxifen (20mg), third day of menstrual cycle for 5 days
Category
Treatment - Drugs

2

Description
Control group: Standard method including 150 mg of Clomiphene daily, with Gonadotropin in sixth, seventh and eighth days of menstrual cycle
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemah Zahra Fertility & Reproductive health training center
Full name of responsible person
Maedeh Ghafori
Street address
Fatemehzahra Fertility & reproductive health training center, Noshirvani street
City
Babol

2

Recruitment center
Name of recruitment center
Mehregan Medical Center
Full name of responsible person
Dr. Zahra Basirat
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
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 and Technology, Babol University 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
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MA/Responsible for Public Affairs of Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
zahra@mubabol.ac.ir , ngh_pa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Zahra Basirat
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
Zahra_Basirat@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemeh Zahra Fertility & Reprodactive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs of Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
Zahra@mubabol.ac.ir ,ngh_pa@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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