Comparison of ovulation induction results with double stimulation protocol (total follicular and luteal phase) and minimum stimulation in patients with poor ovarian response in microinjection cases
Design
In this quasi-experimental randomized clinical trial, which will be conducted on 60 infertile women who come to the Taleghani Center.Women with poor ovarian response in the previous ART cycle will be selected to participate in the project, and in the new cycle a random number table will be used to randomize.Through which participants in this study were divided into two groups, under the luteal and follicular phase stimulation( Double stimulation ) regimen or at minimal stimulation
Settings and conduct
In this quasi-experimental randomized clinical trial, which will be conducted on 60 infertile women who come to the Taleghani Center.Women with poor ovarian response in the previous ART cycle will be selected to participate in the project, and in the new cycle a random number table will be used to randomize.Through which participants in this study were divided into two groups, under the luteal and follicular phase stimulation( Double stimulation ) regimen or at minimal stimulation
Participants/Inclusion and exclusion criteria
Cancellation of the previous cycle due to inadequate ovarian response, and after ovarian stimulation in the previous cycle, less than three follicles and after puncture were obtained less than an oocyte
Intervention groups
Participants in this study were divided into two groups, under the luteal and follicular phase stimulation( Double stimulation ) regimen or at minimal stimulation
Main outcome variables
Number of follicles; number of recovered oocytes; number of canceled cycles; number of embryo-embryo grading; transmitted embryos; pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180908040964N1
Registration date:2018-12-31, 1397/10/10
Registration timing:retrospective
Last update:2018-12-31, 1397/10/10
Update count:0
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
sedighe hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
shosseini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision The Effect of Minimal stimulation and double stimulation protocol in poor ovarian response in ICSI cycle
Public title
Comparision The Effect of Minimal stimulation and double stimulation protocol in poor ovarian response in ICSI cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
In these individuals, the previous cycle was canceled due to insufficient ovarian response. After ovarian stimulation in the previous cycle, less than three follicles and after puncture, less than one ovum were obtained.
Exclusion criteria:
Age
From 20 years old to 38 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We use the numerical random number table to choose the numbers, for example, if the sample size is two digits. First, select a two-digit number completely randomly, for example by placing the pencil tip, and then go ahead and select two-digit numbers to get the required number.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is double-blind study, that the participants do not know which of the two control or test groups belong, and also the observers (researchers) do not know who the group is.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.SBMU.RETECH.REC. کد اخلاق 1397.486
Health conditions studied
1
Description of health condition studied
Patients with poor ovarian response
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Number of follicles
Timepoint
From the tenth day of the cycle
Method of measurement
sonography
2
Description
Number of recovered oocytes
Timepoint
Oocyte recovery day
Method of measurement
observation
3
Description
Number of canceled cycles
Timepoint
Oocyte recovery da
Method of measurement
observation
4
Description
Number of embryo
Timepoint
5 days after Oocyte recovery
Method of measurement
observation
5
Description
embryo grading
Timepoint
5 days after Oocyte recovery
Method of measurement
observation
6
Description
Transmitted embryos
Timepoint
Transfer day
Method of measurement
observation
7
Description
Pregnancy rate
Timepoint
Two weeks after transfer
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: In a double-stimulation protocol based on the Shanghai protocol, Qualified women entered the study in the first phase from the third day of the monthly cycle will receive a daily dose of 25 mg cholomifen citrate for up to a stimilation day. At the same time, letrozole at a dose of 2.5 mg per day from the third day for four days at 150 units, every other day will start. And will receive HMG on the 10th day. When at least 3 follicules have reached 18 mm or a follicle reached 20 mm, the triggering of oocyte with an GNRH agonist will start. 32 to 36 hours after an agonist GNRH injection search and retrieve oocytes from transvaginal sonography will begin and follicles less than 10 mm will remain to second phase in the luteal phase. After ultrasonography, the second phase of stimulition depends on presence of at least 2 anthral follicles with a size of 2 to 8 mm. At this stage 225 Unit HMG with 2.5 mg Letrozole is prescribed daily from the day of recovery of oocyte or one day later. And when the dominant follicle reached 12mm, Letrozole is discontinued and daily administration of medroxyprogesterone acetate at a dose of 10 mg for 3 days will continue for patients with follicles up to 14 cm. And when at least 3 follicules have reached 18 mm or a follicle reached 20 mm,the triggering of oocyte with an GNRH agonist will start again.
Category
Treatment - Drugs
2
Description
Intervention group: In the minimum protocol, colomibsin citrate is prescribed from day 2 to day 5 of the monthly cycle with a dose of 100 mg / day. From day four, 150 HMG units are prescribed. The GNRH antagonist is administered when the dominant follicle reaches 13 or higher and continues until the final trigger day. The ovulation stimulation is performed when the dominant follicle reaches 17 mm.In this HCG recombinant mcg is prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF Infertility and IVF ward of Talghani hospital
Full name of responsible person
Sediqeh Hosseini
Street address
Yaman St., Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Email
shosseini@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farah Farzand
Street address
Shahid Madani Avenue, Imam Hussein Hospital, 3rd Floor, Women's Prevention Research Center
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 2543
Email
M.amirisiavashani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?