Protocol summary

Study aim
The efficacy of Double Ovarian Stimulation for enhancing oocyte yield in assisted reproductive technology in patients with poor ovarian response
Design
En Intervention group: In group A, first a course of contraceptive pills was given to patients and then on the first to third day of mensturation ultrasound was done and cinnafact was administered at a dose of 50 units for three days and on the third day Pergoverisis administered twice daily and only Pergoveris continued. Ultrasound is performed on the fifth day of ovulation stimulation to examine the size of the grown follicles. When one or two follicles reach a size of 18 mm, triggering was done with decapeptyl 0/2 Mg administered simultaneously with 10,000 units HCGa way that three to five days after the initial ovulation, the patient was given two ampoules of Pergoveris again when the size of the follicle reached 18 mm. Triggering was done by decaptil 0/2 mg and HCG 10000 units.
Settings and conduct
Patients with low respons ovarian reserve (poseidn 3,4) IVF and Infertility Center of Taleghani Hospital (Shahid Beheshti UNiversity).
Participants/Inclusion and exclusion criteria
Poor ovarian stimulation based on Poseidon group 3 criteria, AMH less than 1.2 ng / ml, antral follicle count less than 5 and age less than 35 years Group 4 poseidon includes older age equal to 35 years and AMH less than 1.2 ng/ml and the number of antral follicles less than 5 follicles. People with normal or excessive ovarian response will not be included in the study.
Intervention groups
Poor ovarian stimulation based on Poseidon group 3 criteria, AMH less than 1.2 ng / ml, antral follicle count less than 5 and age less than 35 years Group 4 poseidon includes older age equal to 35 years and AMH less than 1.2 ng/ml and the number of antral follicles less than 5 follicles.
Main outcome variables
Number of oocytes, number of embryos, number of blastocysts.

General information

Reason for update
Acronym
Duostim
IRCT registration information
IRCT registration number: IRCT20200804048303N1
Registration date: 2021-07-01, 1400/04/10
Registration timing: prospective

Last update: 2021-07-01, 1400/04/10
Update count: 0
Registration date
2021-07-01, 1400/04/10
Registrant information
Name
Samaneh Sheibani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2223 9220
Email address
samane.sheibani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the efficacy of two methods of Double Ovarian Stimulation for enhancing oocyte yield in assisted reproductive technology in patients with poor ovarian response
Public title
The efficacy of Double Ovarian Stimulation for enhancing oocyte yield in assisted reproductive technology in patients with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Poor ovarian stimulation based on Poseidon group 3 criteria, AMH less than 1.2 ng / ml, antral follicle count less than 5 and age less than 35 years Group 4 poseidon includes older age equal to 35 years and AMH less than 1.2 ng/ml and the number of antral follicles less than 5 follicles Group 4 poseidon includes older age equal to 35 years and AMH less than 1.2 ng/ml and the number of antral follicles less than 5 follicles
Exclusion criteria:
Women with normal or excessive ovarian response Women with excessive ovarian response
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
prospective interventional before and after study

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Preventative Gynecological Research Center
Street address
Taleqani Hospital , Shahid Arabi Ave, Yaman Ave, Shahid Chamran Highway , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1079

Health conditions studied

1

Description of health condition studied
POOR OVERIAN RESPONSE
ICD-10 code
E28.9
ICD-10 code description
Ovarian dysfunction, unspecified

Primary outcomes

1

Description
Number of oocytes.
Timepoint
Compare the number of oocytes and MII oocytes after induction ovulation in the follicular and luteal phase and two methods flare stimulation and minimal stimulation,
Method of measurement
Ultrasonography and puncture of oocytes and evaluate the presence of a polar body.

2

Description
Number of embryos.
Timepoint
Number of embryos after induction ovulation and oocyte retrieval in follicular and luteal phase and compare two methods of flare stimulation and minimal stimulation.
Method of measurement
Inspection of embryos under the microscope.

3

Description
Number of blastocysts.
Timepoint
The number of blastocysts after oocyte retrieval in the follicular and luteal phases and compare the two methods of flare stimulation and minimal stimulation.
Method of measurement
Inspection of embryos under the microscope 5days after oocyte retrieval.

Secondary outcomes

1

Description
Clinical pregnancy
Timepoint
4-6 weeks after embryo transfer(ET)
Method of measurement
Transvaginal ultrasonography and observe existence of gestational sac and fetal heart rate

Intervention groups

1

Description
Intervention group: In group A, first a course of contraceptive pills was given to patients and then on the first to third day of mensturation ultrasound was done and cinnafact was administered at a dose of 50 units for three days and on the third day Pergoverisis administered twice daily and only Pergoveris continued. Ultrasound is performed on the fifth day of ovulation stimulation to examine the size of the grown follicles. When one or two follicles reach a size of 18 mm, triggering was done with decapeptyl 0/2 Mg administered simultaneously with 10,000 units HCGa way that three to five days after the initial ovulation, the patient was given two ampoules of Pergoveris again when the size of the follicle reached 18 mm. Triggering was done by decaptil 0/2 mg and HCG 10000 units.
Category
Treatment - Drugs

2

Description
Intervention group: In group B, after a course of contraceptive pills, on the first to third day of mensturation ultrasound was done, then letrozol 2/5 mg twice a day orally for five days from third day of menstration was started for patients wih injection of one pergoveris per day in 6th and 7th cycle- days. Follicular size was fallowed with transvaginal sonography When leading follicle was reached to 18mm 10,000 units HCG + 0/2 mg decapeptile was given intramuscularly. Then compared the results of the study between the two groups, including the number of oocytes recovered, the number of blastocysts found in the biopsy, the number of embryos transferred and the number of cases of successful clinical fertility.In the luteal phase, the GnRH antagonist will be considered.In such a way that three to five days after the initial ovulation, the patient was given two ampoules of Pergoveris again when the size of the follicle reached 18 mm. Triggering was done by decaptil 0/2 mg and HCG 10000 units.Then compared the results of the study between the two groups, including the number of oocytes recovered, the number of blastocysts found in the biopsy, the number of embryos transferred and the number of cases of successful clinical fertility.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospial
Full name of responsible person
Samaneh Sheibani
Street address
Taleghani hospital , Shahid Arabi Ave,Yaman Ave, Shahid Chamran highway , Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
Talehanihospital@sbmu.ac.ir
Web page address
Http://taleghani.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Afshin Zarghi
Street address
Taleghani Hospital, Shahid Arabi Ave, Yaman Ave, Shahid Chamran Highway, Teharan , Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
TaleghaniHospital@sbmu.ac.ir
Web page address
Http://taleghani.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samaneh Sheibani
Position
Infertility fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti University, Shahid Arabi Ave, Yaman Ave, Shahid Chamran Ave, Teh, Iran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
Taleghanihospital@sbmu.ac.ir
Web page address
Http://taleghani.sbmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samaneh Sheibani
Position
Infertility fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Hospital , Shahid Arabi Ave , Yaman Ave, Shahid Chamran Highway , Teh , Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
TaleghaniHospital@sbmu.ac.ir
Web page address
Http://taleghani.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samaneh Sheibani
Position
Infertility fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Hospital , Shahid Arabi Ave , Yaman Ave , Shahid Chamran Highway, Teh , Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
TaleghaniHospital@sbmu.ac.ir
Web page address
Http://taleghani.sbmu.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, only part of the information about the main outcome can be shared.
When the data will become available and for how long
6month after published article.
To whom data/document is available
Researchers work at university and research parts.
Under which criteria data/document could be used
Analysis for scientific progression and improve treatment.
From where data/document is obtainable
Demand by e.mail to: S.sheibani.pgrc@gmail.com or refer to Taleghani Hospital IVF and Infertility ward.
What processes are involved for a request to access data/document
We can e.mail data for at least one weak delay.
Comments
Loading...