Protocol summary

Study aim
In this study, we decided to determine the effect of oxytocin and Human Chorionic Gonadotropin(HCG) on ovulation and pregnancy.
Design
The randomized double blinded clinical trial in three groups of 42 cases with a parallel group was done.
Settings and conduct
Double blind clinical trial was performed on patients referred to infertility center of Shahid Akbar Abadi Hospital in Tehran. patients and doctors were blinded.
Participants/Inclusion and exclusion criteria
Infertile women with chronic ovulation disorder and polycystic ovarian syndrome (based on Rotterdam criteria 2003), who was treated with clomiphene citrate (150 mg) and did not pregnant, age of 19 to 45 years old, Body Mass Index of 27 to 32, at least one of the ovarian tubes with hysterosalpingography is open and no other pelvic pathology, were included in the study.. Any allergy to oxytocin and cardiovascular disease and other causes of infertility were excluded.
Intervention groups
Clomiphene citrate resistant polycystic ovary syndrome patients were studied.The volunteers with the above conditions were randomly assigned to three separate groups. In the first group, Letrozole and human chorionic gonadotropin, in the second group, Letrozole and oxytocin and in the third group, Letrozole and HCG and oxytocin were given. Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, trans vaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 10-unit of oxytocin and or 5,000-unit HCG were injected.
Main outcome variables
Pregnancy, Abortion, Multiple pregnancy, Dominant Follicle Size, Follicle Count, Endometrial Thickness were analysed.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171031037130N2
Registration date: 2018-05-07, 1397/02/17
Registration timing: registered_while_recruiting

Last update: 2018-05-07, 1397/02/17
Update count: 0
Registration date
2018-05-07, 1397/02/17
Registrant information
Name
Armaghan Eshraghian
Name of organization / entity
Iums
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 6329
Email address
eshraghian@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-25, 1396/08/03
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of oxytocin and human chorionic gonadotropin in clomiphene citrate resistant polycystic ovary syndrome patients
Public title
The effects of Oxytocin on Ovulation and Pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clomiphen citrate resistant poly cystic ovary syndrome patients 19 - 45 years old At least one ovarian tube is open in HSG Normal Semen analysis of husband No other pelvic pathology
Exclusion criteria:
Hypersensitivity to Oxytocin History of Cardio vascular disease Use of anti hypertensive drug blood pressure lower than 60/90 abnormal spermogram hyper prolactinoma anatomical disorder of uterus and tubal factor karyotype disorder
Age
From 19 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after determining the sample size, Patients were randomly assigned to one of three groups using stratified randomization. Allocation Concealment was performed by sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, a plan was first described for the patient.The patient, the researcher and the physician did not know the group. For each treatment, the code was assigned and placed in an envelop and then put in a box, randomly.The agent who conducted the randomization process, did not engage with other steps.
Placebo
Not used
Assignment
Parallel
Other design features

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 Sciences, Shahid Hemmat Highway,
City
tehran
Province
Tehran
Postal code
14665-354
Approval date
2017-10-24, 1396/08/02
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9311290002

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
pregnancy percentage
Timepoint
pregnancy test and sonography after induction of ovulation
Method of measurement
serum beta HCG

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, trans vaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 10-unit of oxytocin were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies
Category
Treatment - Drugs

2

Description
Intervention group 2: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, transvaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 5,000-unit HCG were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies
Category
Treatment - Drugs

3

Description
Intervention group 3: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, transvaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 10-unit of oxytocin and 5,000-unit HCG were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Science
Full name of responsible person
Armaghan Eshraghian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway,
City
tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Fax
+98 21 8805 2248
Email
PR@iums.ac.ir
Web page address
http://iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sied Kazem Malakooti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway,
City
tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8670 2503
Fax
Email
research@iums.ac.ir
Web page address
http://iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojgan Javedani Masroor
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Akbar abadi hospital, Molavi intersectino, Molavi Ave,
City
tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
javedanimasroor.m@iums.ac.ir
Web page address
http://crta.iums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojgan Javedani Masroor
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Akbar abadi hospital, Molavi intersectino, Molavi Ave,
City
tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
javedanimasroor.m@iums.ac.ir
Web page address
http://crta.iums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojgan Javedani Masroor
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Akbar abadi hospital, Molavi intersectino, Molavi Ave,
City
tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
javedanimasroor.m@iums.ac.ir
Web page address
http://crta.iums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...