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Evaluation of the effect of pretreatment of E2 and OCP before Antagonist cycle on IVF outcome.

Protocol summary

Summary
Worldwide, gonadotrophin-releasing hormone (GnRH) antagonists are gaining ground, and. During the past 2 years, debate has been ongoing about the possible disadvantages of oral contraceptive pill (OCP) pre-treatment in GnRH antagonist IVF cycles. Therefore, this study aimed the whether or not OCP pre-treatment might have effect on outcome in GnRH antagonist IVF cycles. This is single blind Clinical Trial study and will be done on 195 patients that candidate to IVF from winter 1395 to spring the year of 1396 in infertility center of Imam Khomeini hospital patients with inclusion criteria (women with 20-35 years old; without any pathology in ovary or endometrioma, myoma or any hydrosalpinx ) are divided randomly to 3 groups. In group 1 ( 65 patients ) only antagonist 25 miligram daily is administrated from the second day of the cycle. In group 2 ( 65 patients), daily treatment is a pill (OCP) for 10 days and 10-12 days before the last cycle. In group 3, daily treatment is a Estradiol Pill for 10 days and before the start of antagonist administration. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done. In all three groups, the number of oocyte, days of stimulation as a primary outcomes and chemical and clinical pregnancy rates will be considered as a secondary outcome.This is single blind study that analyzer is blinded for the 3 treatment groups.

General information

Acronym
OCP; E2; Antagonist
IRCT registration information
IRCT registration number: IRCT2017020520351N9
Registration date: 2017-02-21, 1395/12/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-21, 1395/12/03
Registrant information
Name
Ensieh Shahrogh Tehraninejad
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
etehraninejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Science.
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of pretreatment of E2 and OCP before Antagonist cycle on IVF outcome.
Public title
Evaluation of the effect of pretreatment of E2 and OCP in Antagonist cycle In IVF cycles.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with 20-35 years old; prior IVF less than 2; AFC>4; FSH<10; without any pathology in ovary or endometrioma more than 1cm; without any hydrosalpinx. Exclusion criteria: PCOS; pathology in uterus or ovary ( myoma larger than 5 cm); absence of vaginal bleeding until 6 days after disconnection of OCP or E2; lack of permission of patients.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 195
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Building, Tehran University of Medical Sciences, Ghods Street,
City
Tehran
Postal code
14194
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
92345

Health conditions studied

1

Description of health condition studied
Female infertility associated with anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility, unspecified

Primary outcomes

1

Description
Oocyte number
Timepoint
Six days after treatment
Method of measurement
Vaginal sonography

2

Description
Number of induction ovulation
Timepoint
After treatment
Method of measurement
Transvaginal sonography

Secondary outcomes

1

Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
B-HCG Test

2

Description
Clinical pregnancy
Timepoint
Three weeks after do positive of pregnancy teset
Method of measurement
Transvaginal sonography

Intervention groups

1

Description
In group without intervention ( Control): only antagonist 25 miligram daily is administrated from the second day of the cycle. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done.
Category
Treatment - Drugs

2

Description
In intervention group 1: daily treatment is a pill (OCP) for 10 days and 10-12 days before the last cycle. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done.
Category
Treatment - Drugs

3

Description
In intervention group 2: daily treatment is a Estradiol Pill for 10 days and before the start of Antagonist administration. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Infertility Clinic
Full name of responsible person
Dr. Fatemeh Bakhtiari
Street address
Valiasr Infertility Clinic, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Floor N.6, Central Bulding,Tehran University of Medical Sciences, Ghods Street.
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, Tehran 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
Reproductive Health Research Center
Full name of responsible person
Fatemeh Bakhtiari
Position
Infertility Flowship
Other areas of specialty/work
Street address
First floor, Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
14194
Phone
+98 21 6658 1658
Fax
Email
bakhtiyari1355@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Farnaz Sohrabvand
Position
Professor
Other areas of specialty/work
Street address
First floor, Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
14194
Phone
+98 21 6658 1658
Fax
+98 21 6658 1658
Email
fsohrabvand@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vali Asr Reproductive Health Research Center
Full name of responsible person
Fedyeh Haghollahi
Position
Expert in Research
Other areas of specialty/work
Street address
First floor, Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
14194
Phone
+98 21 6658 1658
Fax
+98 21 6658 1658
Email
fedyeh_hagh@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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