Comparison of double stimulation protocol to the approach using antagonist with high dose of gonadotropin in patients with poor ovarian response in avicenna infertility center
Investigation and comparison of the results of microinjection using the Double Stimulation protocol with high dose gonadotropin-antagonist protocol in patients with POR.
Design
Study type: Randomized clinical trial .
Study group: Sixty patients with POR who nominated for microinjection and divided randomly into two groups of 30.
Settings and conduct
Firstly, the probable side effects of drugs competently were explained to the patients and written consents were obtained.
In Double Stimulation group letrozol and clomifin pills were administrated since day 2, and gonadotropin since day 4 .
In another group is started from 2 days after period and 450-600 units gonadotropin were used. Depending on ovules response the doses are adjusted. Both groups are investigated in terms of number and quality of ovules and embryos, pregnancy condition, and serum levels of progesterone, FSH, LH, and Estradiol.
The study will be carried out in Tehran Avicenna infertility center.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Aged over 40; history of less than 4 oocyte; abnormal ovarian reserve tests; previous ovary surgery; risk factors in weak ovary response.
Exclusion criteria
BMI value: 35 and higher; FSH more than 25; grade 3 endometriosis and higher; any contraindication for ovarian stimulation like uncontroled systemic dieases; intense male infertility according to WHO indexes
Intervention groups
Aim: improving ovarian response in POR patients. The effectiveness of two antagonist protocols with high doses of Gonadotropin and twice stimulation in follicular and luteal phases in terms of the number and quality of ovules and embryo will be carried out and finally the fertility rates will be compared.
Main outcome variables
Successful fertility rate, improved number and quality of embryos and ovules, high And qualitative , improved rate of chemical and clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180219038792N1
Registration date:2019-01-02, 1397/10/12
Registration timing:retrospective
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Farnaz Montazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23519
Email address
f.montazeri@ari.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of double stimulation protocol to the approach using antagonist with high dose of gonadotropin in patients with poor ovarian response in avicenna infertility center
Public title
Comparison of double stimulation protocol with high dose of gonadotropin protocol in patients with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 40.
History of getting less than four oocyte retival in previous cycle
Abnormal ovarian reserve tests.
History of previous ovarian surgery or history of chemotherapy
Different risk factors involved in ovarian response weakness
Exclusion criteria:
BMI value is equal to 35 and higher
FSH more than 25
Grade 3 endometriosis and higher
Any contraindication for ovarian stimulation such as uncontrolled systemic diseases
Sever male infertility based on WHO indexes
Age
From 40 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A random specific code was allocated for each of 500 poor responders. A sample size of 60 was calculated based on the relating formula. 60 patients with poor response were randomly selected and divided into two groups of 30. Group A was selected for intervention and group B was considered as control.
Measuring the number of follicles in the first menstrual cycle and after taking ovulation-inducing drugs
Method of measurement
Ultrasouand system
2
Description
The number and quality of the obtained embryos
Timepoint
In follicular and luteal phase
Method of measurement
Ultrasouand system
3
Description
Measurement of serum Progesterone
Timepoint
On the day the gonadotropins started, and on the day of the trigger with Deca in the follicular and luteal phase
Method of measurement
ELISA
4
Description
Measurement of serum E2,
Timepoint
On the day the gonadotropins started, and on the day of the trigger with Deca in the follicular and luteal phase
Method of measurement
ELISA
5
Description
Measurement of serum LH
Timepoint
On the day the gonadotropins started, and on the day of the trigger with Deca in the follicular and luteal phase
Method of measurement
ELISA
6
Description
Measurement of serum FSH
Timepoint
On the day the gonadotropins started, and on the day of the trigger with Deca in the follicular and luteal phase
Method of measurement
ELISA
7
Description
The quantity of retrieved oocytes
Timepoint
Measuring in the first menstrual cycle and after taking ovulation-inducing drugs
Method of measurement
Ultrasouand system
Secondary outcomes
1
Description
The amount of pregnancy and successful birth
Timepoint
After 9 months
Method of measurement
Number of successful pregnancies and live births
Intervention groups
1
Description
This study is a prospective randomized clinical trial. Patients who are nominated for ICSI because of POR are divided into two groups of 30 individuals randomly. After completing the consent, they will be placed in Double Stimulation group or a high dose antagonist gonadotrophin. First group, the starting day of the menstrual period begins with letrozole and clomiphene, and from the fourth day starts 150 units of gonadotrophin.
Category
Treatment - Drugs
2
Description
Control group: second group from the second day of the menstrual cycle, gonadotrophin starts at a dose of 450-400 units, and the dose is adjusted depending on the response of the ovaries. Both groups were evaluated for the number and quality of oocytes and embryos obtained, pregnancy status and serum levels of FSH, LH, Estradiol, Progesterone.