Protocol summary

Study aim
To assess the effect of oral contraceptive with gonadotropin-releasing hormone (GnRH) agonist versus Estradiol Valerate on the pregnancy continuity after a frozen embryo transfer in infertile women
Design
This is a double-blind randomized clinical trial, phase II, in which 100 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible infertile women referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 40 years, Infertile women candidate for the embryo transfer process, Having more than 3 embryos for transfer, Having a healthy uterine cavity, Having constant embryo culture medium, Having a constant embryo transfer environment, Having constant fetal quality, Having fixed embryology, Exclusion criteria: Being a smoker, Idiopathic infertility, Patients with donated oocytes,
Intervention groups
Intervention group: Oral contraceptive pill once daily form the second day of the menstrual cycle for 12 days plus a subcutaneous injection of GnRH agonist 0.5 mg daily from the 15th day of the menstrual cycle for 14 days Control group: Estradiol Valerate tablet (manufactured by Abureihan Pharmaceutical Co.) 6 mg twice a day from the second day of the menstrual cycle for at least 10 days
Main outcome variables
Primary outcome: Pregnancy continuity, Secondary outcome: Ectopic pregnancy, polygamous pregnancy, spontaneous abortion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N342
Registration date: 2020-03-04, 1398/12/14
Registration timing: retrospective

Last update: 2020-03-04, 1398/12/14
Update count: 0
Registration date
2020-03-04, 1398/12/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral contraceptive with gonadotropin-releasing hormone (GnRH) agonist versus Estradiol Valerate on the pregnancy continuity after frozen embryo transfer in infertile women: a double-blind randomized clinical trial
Public title
Effect of oral contraceptive with gonadotropin-releasing hormone (GnRH) agonist versus Estradiol Valerate on the pregnancy continuity after frozen embryo transfer in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years, Infertile women candidate for the embryo transfer process, Having more than 3 embryos for transfer, Having a healthy uterine cavity, Having constant embryo culture medium, Having a constant embryo transfer environment, Having constant fetal quality, Having fixed embryology,
Exclusion criteria:
Being a smoker, Idiopathic infertility, Patients with donated oocytes,
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 128
More than 1 sample in each individual
Number of samples in each individual: 64
64 infertile women will be assigned to the intervention group and 64 to the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be given in coded envelopes. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-08-20, 1398/05/29
Ethics committee reference number
IR.UMSHA.REC.1398.337

Health conditions studied

1

Description of health condition studied
Artificial fertilization
ICD-10 code
N98
ICD-10 code description
Complications associated with artificial fertilization

Primary outcomes

1

Description
Pregnancy continuity after embryo transfer
Timepoint
12 weeks after the intervention
Method of measurement
With ultrasonography

Secondary outcomes

1

Description
Ectopic pregnancy
Timepoint
12 weeks after the intervention
Method of measurement
With ultrasonography

2

Description
Polygamous pregnancy
Timepoint
12 weeks after the intervention
Method of measurement
With ultrasonography

3

Description
Spontaneous abortion
Timepoint
12 weeks after the intervention
Method of measurement
With ultrasonography

Intervention groups

1

Description
Oral contraceptive pill once daily form the second day of the menstrual cycle for 12 days plus a subcutaneous injection of GnRH agonist 0.5 mg daily from the 15th day of the menstrual cycle for 14 days
Category
Treatment - Drugs

2

Description
Control group: Estradiol Valerate tablet (manufactured by Abureihan Pharmaceutical Co.) 6 mg twice a day from the second day of the menstrual cycle for at least 10 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr Fatemeh Jamshidi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
fatemejam13655@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Fatemeh Jamshidi
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fatemejam13655@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Soghra Rabiri
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
rabieesogol@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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