The informed consent was taken from the patients before the beginning of the study. In group 1 the patients takes OCP for two month before IVF then received a standard controlled ovarian hyperstimulation (COH) regimen. It consisted of subcutaneous injections of 0.05 to 0.1 mg/day of a GnRH agonist (Diphereline 0.1 mg) for 7 to 10 days in the mid-luteal phase for pituitary down-regulation, and exogenous ovarian stimulation with gonadotropin was initiated on the second or third day after the onset of menstruation. In group 2 the patients received a 3.75-mg intramuscular injection of a GnRH agonist (Diphereline) twice, at a 28 days' interval. Controlled ovarian hyperstimulation was initiated within 10 days of the last GnRH agonist injection. Ovarian stimulation was achieved using FSH (Gonal-F ;) and/or human menopausal gonadotropin. Human chorionic gonadotropin (hCG) was administered to trigger egg maturation when at least 1 follicle achieved a mean diameter of 17 mm. The patients were scheduled for oocyte retrieval 34 to 36 hours after the hCG injection. Indications and techniques for oocyte aspiration, oocyte and embryo culture, insemination, intracytoplasmic sperm injection, and embryo transfer were based on the routine of the center. Embryos were transferred at the 4- or 8- cell stage. Response to controlled ovarian hyperstimulation and IVF– ET cycle outcome were compared between groups. Clinical pregnancy was defined as an elevated serum hCG and the presence of a gestational sac on transvaginal ultrasound. Implantation rate was defined as number of ultrasonographically visualized gestational sacs per number of embryos transferred. Ongoing pregnancy was defined as a uterine pregnancy of more than 12 weeks' duration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409301556N64
Registration date:2014-10-11, 1393/07/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-11, 1393/07/19
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-10-12, 1393/07/20
Expected recruitment end date
2016-12-01, 1395/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the pregnancy outcomes of IVF between GnRH-a and OCP in women with moderate and sever endomethriosis.
Public title
Effect of GnRH-a and OCP on the result of IVF in females with moderate and sever endomethriosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Hundred infertile women with moderate and sever endomethriosis according to the revised American Fertility Society classification were scheduled for IVF.
These patients were in line with: moderate and sever endometriosis; age less than 35 years old; FSH level below 10 U/L; 27>BMI>20. Exclusion criteria: minimal and mild endometriosis; potentialy poor responder; endocrine disorders.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Ghods Avn., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2003-05-27, 1382/03/06
Ethics committee reference number
/130/514/د/93
Health conditions studied
1
Description of health condition studied
Endomethriosis
ICD-10 code
N80
ICD-10 code description
Noninflammatory disorders of female genital tract
Primary outcomes
1
Description
Number of retrieved oocytes
Timepoint
Oocyte retrieval 34 to 36 hours after the hCG injection
Method of measurement
Base on microscopic finding
2
Description
Number of MII oocytes
Timepoint
MII oocytes after retrieval
Method of measurement
Base on microscopic finding
3
Description
Fertilization rate
Timepoint
Fertilization was assessed by pronuclei formation at 24 h after oocyte retrieval and by subsequent cleavage
Method of measurement
Base on microscopic finding
4
Description
Implantation rate
Timepoint
Implantation rate was defined as number of ultrasonographically visualized gestational sacs
Method of measurement
Ultrasonography
5
Description
The number of embryo transfer
Timepoint
Day 2 or day 3 embryos were transferred
Method of measurement
pationt's file
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Ongoing pregnancy was defined as a uterine pregnancy of more than 12 weeks' duration
Method of measurement
Ultrasonography
2
Description
pregnancy rate per embryo transfer
Timepoint
pregnancy rate was defined as number of ultrasonographically visualized gestational sacs per number of embryos transferred
Method of measurement
ultrasonography
Intervention groups
1
Description
Hundred infertile women with mod and sever endomethriosis according to the revised American Fertility Society classification were scheduled for IVF.
In interventional group(50) the patients takes OCP for 6-8 Weeks before IVF then received a standard
controlled ovarian hyperstimulation (COH) regimen. It consisted
of subcutaneous injections of 0.05 to 0.1 mg/day of a GnRH
agonist (Diphereline 0.1 mg) for 7 to 10 days in the mid-luteal phase
for pituitary down-regulation, and exogenous ovarian stimulation
with gonadotropin was initiated on the second or third day
after the onset of menstruation . Human chorionic gonadotropin (hCG) was administered to trigger egg maturation when at least 1 follicle achieved a mean diameter of 17 mm. The patients were scheduled for oocyte retrieval 34 to 36 hours after the hCG injection. Indications and techniques for oocyte aspiration, oocyte and
embryo culture, insemination, intracytoplasmic sperm injection,, and embryo transfer were based on the
routine of the center. Embryos were transferred at the 4- or 8-
cell stage.
Response to controlled ovarian hyperstimulation and IVF–
ET cycle outcome were compared between groups. Clinical
pregnancy was defined as an elevated serum hCG and the
presence of a gestational sac on transvaginal ultrasound.
Implantation rate was defined as number of ultrasonographically
visualized gestational sacs per number of embryos
transferred. Ongoing pregnancy was defined as a uterine
pregnancy of more than 12 weeks' duration.
Category
Treatment - Drugs
2
Description
Hundred infertile women with mod and sever endomethriosis according to the revised American Fertility Society classification were scheduled for IVF .
In control group(50) the patients received a 3.75-mg
intramuscular injection of a GnRH agonist (Diphereline) twice,
at a 28 days' interval. Controlled ovarian hyperstimulation was
initiated within 10 days of the last GnRH agonist injection.
Ovarian stimulation was achieved using FSH (Gonal-F;) and/or human menopausal gonadotropin . Human chorionic gonadotropin (hCG) was administered
to trigger egg maturation when at least 1 follicle achieved a
mean diameter of 17 mm. The patients were scheduled for
oocyte retrieval 34 to 36 hours after the hCG injection.
Indications and techniques for oocyte aspiration, oocyte and
embryo culture, insemination, intracytoplasmic sperm injection,, and embryo transfer were based on the
routine of the center. Embryos were transferred at the 4- or 8-
cell stage.
Response to controlled ovarian hyperstimulation and IVF–
ET cycle outcome were compared between groups. Clinical
pregnancy was defined as an elevated serum hCG and the
presence of a gestational sac on transvaginal ultrasound.
Implantation rate was defined as number of ultrasonographically
visualized gestational sacs per number of embryos
transferred. Ongoing pregnancy was defined as a uterine
pregnancy of more than 12 weeks' duration