Protocol summary

Summary
The aim of this study is to compare pregnancy rates of exogenous protocols and ovarian stimulation Protocols with natural protocol in women undergoing receiving blastocyst embryo freezing. In this randomized clinical trial, 150 patient with inclusion criteria (all healthy women 18 to 40 years, etc.) And exclusion criteria (sever Endometriosis, etc.) are selected. No drug is given for the control group (natural). While follicles reach to 18-20 mm, shape and thickness of the endometrium are noted. After 36-38 hours ovulation is confirmed by vaginal ultrasound and in 4 days blastocyst is transferred. In the first intervention experimental group (Stimulation), patients are taken Clomiphene Citrate tablets 100 mg daily from the fifth day to the ninth day of the cycle. While follicles reach to 18-20 mm, shape and thickness of the endometrium are noted. After 36-38 hours ovulation is confirmed by vaginal ultrasound, and blastocyst is transferred in 4 days. In the second intervention experimental group (Artificial), from the third day of the cycle, Estradiol vale rate tablets 6 mg is given per day. When the endometrial thickness is greater than 8 mm, the shape and thickness of the endometrium is noted. From this special day, 100 mg injection of progesterone along with Estradiol is given daily. Five days after starting progesterone, blastocyst is transferred. If the endometrial thickness doesn't get more than 8 mm in 15th day, Estradiol dose will be increased to 8 mg. In this method, the progesterone as a support would be continued till clarifying the pregnancy test in consistency with getting positive of pregnancy test until sixth week to eighth week of pregnancy. At the end, the primary outcome, number of pregnancies and abortions done in the artificial and stimulation protocols with natural protocol in women undergoing freeze blastocyst transfer are compared. Hence, secondary outcome, endometrial thickness and shape in two protocols Stimulation and artificial with natural protocol are compared as well.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201408021760N36
Registration date: 2014-09-17, 1393/06/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-17, 1393/06/26
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,Babol University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy rate in artificial and stimulation cycles with natural cycle in women candidate vitrified
Public title
Comparison of pregnancy rate in artificial and stimulation cycles with natural cycle in women candidate vitrified
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All healthy women 18 to 40 years with a BMI = 20-32 Exclusion criteria: Women with PCOs; untreated thyroid disorders; Severe Endometriosis; Patients with one ovarian or uterine and ovarian pathology; FSH more than 15 IU / LI on day 3 of the cycle; Poor Response; Smokers; Abnormalities of the uterus;   Patients with diet changes and medication from 2 months ago; Professional Athletes
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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
Ganjafroz Avenue, Babol University of Medical sciences
City
Babol
Postal code
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
4232/30/ژ/پ

Health conditions studied

1

Description of health condition studied
In vitro fertilization
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization

Primary outcomes

1

Description
Pregnancy
Timepoint
Sixth week until the eighth week after embryo transfer
Method of measurement
SONO - Vaginal

2

Description
The number of abortions performed
Timepoint
After 10 weeks of gestational sac formation
Method of measurement
clinical

Secondary outcomes

1

Description
Form Endometrium
Timepoint
Day of HCG injection
Method of measurement
SONO - Vaginal

Intervention groups

1

Description
Intervention Group 2: In the second intervention experimental group (Artificial), from the third day of the cycle, Estradiol vale-rate tablets 6 mg is given per day. When the endometrial thickness is greater than 8 mm, the shape and thickness of the endometrium is noted. From this special day, 100 mg injection of progesterone along with Estradiol is given daily. Five days after starting progesterone, blastocyst is transferred. If the endometrial thickness doesn't get to more than 8 mm in 15th day, Estradiol dose will be increased to 8 mg. In this method, the progesterone as a support would be continued till clarifying the pregnancy test in consistency with getting positive of pregnancy test until sixth week to eighth one of pregnancy
Category
Treatment - Drugs

2

Description
Intervention Group 1: In the first intervention experimental group (Stimulation), patients are taken Clomiphene Citrate tablets 100 mg daily from the fifth day to the ninth day of the cycle. While follicles reach to 18-20 mm, shape and thickness of the endometrium are noted. After 36-38 hours, ovulation is confirmed by vaginal ultrasound, and blastocyst is transferred in 4 days.
Category
Treatment - Drugs

3

Description
Control Group: No drug is given for the control group (natural). While follicles reach to 18-20 mm, shape and thickness of the endometrium are noted. After 36-38 hours, ovulation is confirmed by vaginal ultrasound and in 4 days blastocyst is transferred.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemehzahra Fertility & infertility hospital
Full name of responsible person
Dr. Otoufeh Sheikhi
Street address
Fatemeh-zahra Infertility and Reproductive Health Research Center, Old Road, Amol- Babol, After Mohammad Hassan Khan Bridge
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical sciences, Ganjafroz 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,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 Infertility & reproductive Health Reseach Center
Full name of responsible person
Fr. Otoufeh Sheikhi
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemeh-zahra Infertility and Reproductive Health Research Center, Old Road, Amol- Babol, After Mohammad Hassan Khan Bridge
City
Babol
Postal code
Phone
+98 11 3227 4881
Fax
Email
Drsheikhi58@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemehzahra Infertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Seddigheh Esmaeilzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemeh-zahra Infertility and Reproductive Health Research Center, Old Road, Amol- Babol, After Mohammad Hassan Khan Bridge
City
Babol
Postal code
Phone
+98 11 3227 4881
Fax
Email
sesmael@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
Master of Science
Other areas of specialty/work
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
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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