Review and comparison the success rate, using medroxy progesterone acetate instead of GNRH antagonis, in patients undergoing intracytoplasmic sperm injection (ICSI) by using oocyte donation, single-blind clinical trial
Review and comparison the success rate, using Medroxyprogesterone acetate instead of GNRH antagonist in patients undergoing ICSI by using oocyte donation
Design
Clinical trial with control group, with parallel groups, single- blind, randomized
Settings and conduct
All infertile patients with oocyte donation undergoing ICSI, they are referred to private infertility clinic of Rasht, which are selected according to inclusion criteria. After giving explanations to individual, they are randomly divided.
Intervention groups are unaware of how to intervene.To intervene to participants Medroxyprogesterone acetate is prescribed and fertility success rate will be measured by measuring the pregnancy's blood test.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all infertile patients with oocyte donation undergoing ICSI.
Exclusion criteria: all patients are in case of side effects of the drug or lack of regular use of the drug.
Intervention groups
Intervention group: all infertile patients with oocyte donation under ICSI, which received 2 tablets of Medroxyprogesterone from the first day of the visit until the injection of HCG. The control group will receive the usual treatment.
Main outcome variables
Fertility success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081007001306N10
Registration date:2019-07-31, 1398/05/09
Registration timing:prospective
Last update:2019-07-31, 1398/05/09
Update count:1
Registration date
2019-07-31, 1398/05/09
Registrant information
Name
Ziba Zahiri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
drzibazahiri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review and comparison the success rate, using medroxy progesterone acetate instead of GNRH antagonis, in patients undergoing intracytoplasmic sperm injection (ICSI) by using oocyte donation, single-blind clinical trial
Public title
Review and comparison the success rate, using medroxy progesterone acetate instead of GNRH antagonist,in patients undergoing intracytoplasmic sperm injection (ICSI) by using oocyte donation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infertile patients with oocyte donation undergoing ICSI
Exclusion criteria:
In the oocyte donor:Age over 30 years, irregular menstruation, antral follicle count less than 5 and more than 12, FSH more than 10 on the third day of menstruation, cystic ovaries and endometriosis, BMI greater than 25, not having at least one child and the presence of any disease affecting ovulation (such as thyroid disease and high prolactin levels)
In the oocyte receptor: Age over 45 years , any systemic disease including hypertension, diabetes, chronic diseases, liver and kidney, problem in the uterus and tubes (including: leiomyoma, polyp, adenomyosis, ashren and hydrosalpinx and etc.) and there is male factor
Age
From 20 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
216
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be generated by Random Allocation software, each of which is placed in a separate package according to the software list and closed it and gave it to a third person . In case of referral of the patient and his eligibility,the envelope is opened and It is treated based on the desired sequence without notice of the next treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant will be unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave
City
Rasht
Province
Guilan
Postal code
66949- 41446
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.GUMS.REC.1398.148
Health conditions studied
1
Description of health condition studied
Infertility in female
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Fertility success
Timepoint
Two weeks after fetal transfer
Method of measurement
Pregnancy test
Secondary outcomes
1
Description
Seeing fetal heart rate
Timepoint
6 weeks after fetal transfer
Method of measurement
Vaginal ultrasound
Intervention groups
1
Description
Intervention group: prescription two tablets of Medroxyprogesterone containing 5 mg; manufactured by Abouryan company; Iran; from the first day of the visit until receiving HCG
Category
Treatment - Drugs
2
Description
Control group: Receive routine treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
private clinic
Full name of responsible person
Ziba Zahiri
Street address
3th Floor,Busar Building,Golsar Cross St
City
Rasht
Province
Guilan
Postal code
4135663311
Phone
+98 13 3211 0812
Email
drzibazahiri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice-chancellorship, Guilan University of Medical Sciences
Full name of responsible person
shadman Nemati
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave
City
Rasht
Province
Guilan
Postal code
66949- 41446
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice-chancellorship, Guilan 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
Rasht University of Medical Sciences
Full name of responsible person
Ziba Zahiri
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra hospital, Namjoo Ave
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
drzibazahiri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ziba Zahiri
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Namjoo Ave
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
drzibazahiri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
Candidate, MS of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Al-Zahra hospital, Namjoo Ave
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 33369224
Email
h_fertility@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The release plan is still unknown
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available