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Evaluation of the effect of dopamine D2 antagonist on the success of invitro fertilization in poor responders

Protocol summary

Summary
Compare oocyte counts, mature oocyte count, fertilization rate,cleavage rate, valid embryo count, clinical pregnancy rate, implantation rate, spontaneous abortion rate, in IVF cycle in poor responders that received dopamine D2 antagonist and control group. 50 poor responder patients according to Bologna criteria after taking testimonial form divided to 2 groups, case and control. (Bologna criteria: previous treatment using conventional protocols that yielded less than 3 oocytes, AMH<0.5-1.1 ng/ml or AFC<5-7 Follicles, age over 40 years or any risk factor that decrease the ovarian reserve) side effects are most important excluding factors. First group received metoclopramide 1Tab(10mg)4 times in a day (pre prandial and at the bed time) for 4 weeks and then start IVF cycle when continue the drug. IVF cycle start as antagonist protocol with gonadotropins 450 IU/day, at last pick up done after triggering with HCG. Drugs, Metoclopramide or placebo have the same packages but special codes. Each person including the study does not know which pocket is Metoclopramide or placebo and our study is completely double- blind. After taking all datas, code of drug pockets will be opened and the conclusion will exclaim according to it. At last 2 groups of case and control will be compared by number and quality of oocytes that retrived and fertilization rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015082622206N2
Registration date: 2016-06-19, 1395/03/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-19, 1395/03/30
Registrant information
Name
Alamtaj Samsami
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 9715
Email address
samsamia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for Medical Sciences research of Shiraz University
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dopamine D2 antagonist on the success of invitro fertilization in poor responders
Public title
Effect of Metoclopramide on fertility in women with loss of ovarian reserve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: previous treatment using conventional protocols that yield less than 3 oocytes, abnormal ovarian reserve tests as AMH<0.5-1. 1ng/ml or AFC <5-7 Follicles, age over 40 years or any other risk factor that decrease the ovarian reserve such as previous ovarian surgery, genetic problems, chemotherapy, radiotherapy and autoimmune disease, having 2 or more of above factors (Bologna criteria). Exclusion criteria: not have above factors, no agreement of patient, she can not complete the coarse of treatment, become OHSS. (ovarian hyperstimulation syndrom)
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Shiraz University Of Medical Science
Street address
Building of Shiraz University Of Medical Science, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2015-07-12, 1394/04/21
Ethics committee reference number
IR.sums.rec.1394.70

Health conditions studied

1

Description of health condition studied
patients with poor ovarian response
ICD-10 code
(P00-P96
ICD-10 code description
Certain conditions originating in the perinatal period

Primary outcomes

1

Description
Quality and number of ovum and embryo have received in each IVF cycle.
Timepoint
On day of ovum pick up and embryo transfer
Method of measurement
Measuring number and quality of oocyte on the day of pick up in lab by embryologist under microscope (GV,MI,MII) and quality of embryo also by the same embryologist according to kind of cell division (grade I,II,III,IV)

Secondary outcomes

1

Description
Clinical pregnancy or spontanous abortion
Timepoint
7-12 weeks after embryo transfering
Method of measurement
Serum BHCG and TVS

Intervention groups

1

Description
Interventional group: Metoclopramide 10 mg 4 times/day (pre prandial and at the bed side) The drug started 4 weeks before starting IVF cycle and continued till triggering with HCG.
Category
Treatment - Drugs

2

Description
Control group: similar placebo effect drugs with the same dose. (pre prandial and at the bed side) The drug started 4 weeks before starting IVF cycle and continued till triggering with HCG.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Ghadir Mother and Child Subspecialized Hospital
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Medical Sciences Research of Shiraz University
Full name of responsible person
Dr Syed Baser Hashemi
Street address
7th Floor dean of research, Building of University Of Medical Science, Zand Street, Shiraz , Fars , Iran, Islamic Republic
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Medical Sciences Research of Shiraz University
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
Shiraz Unicversity of Medical Sciences
Full name of responsible person
Dr Pardis Bakhshaeie
Position
Fellowship Infertility
Other areas of specialty/work
Street address
Infertility Research Center Shiraz ,Fars ,Iran, Islamic Republic
City
Shiraz
Postal code
Phone
+98 912 363 0119
Fax
Email
Pardis.bakhshaie287@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Univcersity of Medical Sciences
Full name of responsible person
Dr Alamtaj Samsami
Position
Professor
Other areas of specialty/work
Street address
Infertility Research Center , Shiraz, Fars , Iran, Islamic Republic
City
Shiraz
Postal code
Phone
+98 917 315 2795
Fax
Email
Samsamia@sums.ac.ir, hafez_perina@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pardis Bakhshaie
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Infertility Research Center , Shiraz, Fars , Iran, Islamic Republic
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

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