Clinical trail of comparison of pregnancy outcome in delay gonadotropin releasing hormone(GnRH) antagonist versus microdose flare GnRH agonist protocol in infertile poor ovarian responder women undergoing in vitro fertilization/ intra cytoplasmic sperm injection (IVF/ ICSI) cycles
This is a clinical trial phase 3 study which compares pregnancy outcome in delay gonadotropin releasing hormone(GnRH) antagonist versus microdose flare GnRH agonist protocol in infertile poor ovarian responder women undergoing in vitro fertilization/ intra cytoplasmic sperm injection (IVF/ ICSI) cycles. This study is conducted on 100 infertile women with poor ovarian response without sever male factor between 18 to 42 years old who admit to Yazd research and clinical center between September 2016 and December 2016 who candidate for IVF/ICSI cycles. A microdose GnRH agonist flare up to 50 patients (group 1) and a delay GnRH antagonist protocol to another 50 patients (group 2) are applied randomly with randomized allocation software. Ovarian stimulation according to protocols is initiated in both groups. Final oocyte maturation is triggered in both groups with 10,000 unit human chorionic gonadotropin (HCG) when the largest two follicles attain a mean diameter of 17 millimeter. Oocyte retrieval is performed under transvaginal ultrasound guidance 36 hours after HCG administration. In this two groups dominant follicles, mature oocytes retrieved, fertilization rate and clinical pregnancy rate are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071628950N1
Registration date:2016-10-20, 1395/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-20, 1395/07/29
Registrant information
Name
Nosrat Neghab
Name of organization / entity
Research and Clinical center for Infertility, Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
nosratneghab@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trail of comparison of pregnancy outcome in delay gonadotropin releasing hormone(GnRH) antagonist versus microdose flare GnRH agonist protocol in infertile poor ovarian responder women undergoing in vitro fertilization/ intra cytoplasmic sperm injection (IVF/ ICSI) cycles
Public title
Effect of treatment protocol on pregnancy outcome in infertile poor ovarian responder women undergoing in vitro fertilization/ intra cytoplasmic sperm injection (IVF/ ICSI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infertile women between 18 to 42 years old with ≤8 antral follicle count in bilateral
ovaries; and or patients with basal follicle stimulating
hormone (FSH) ≥ 9 milli unit per milliliter; and or patients with a
history of cancelled invitro fertilization(IVF) cycle ≤3 dominant follicles; and or
≤500 pico mole per liter estradiol (E2) levels at human chorionic gonadotropin( hCG) administration day.
Exclusion criteria: patients under 18 years old or over 42 years old; patients with sever male factor
Age
From 18 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized allocation with computerized program we divide the patients randomly in intervention and control groups with table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
IR.SSU.RSI.REC.1395.3
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility ,unspecified
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
28 days after transfer
Method of measurement
Vaginal sonography
Secondary outcomes
1
Description
Number of mature oocytes
Timepoint
Oocyte pucture day
Method of measurement
Number of M2 oocytes
Intervention groups
1
Description
In interventional group delay Gn RH antagonist protocol for controlled ovarian hyper stimulation is used. All patients are received estrogen tablet 2 milligram daily starting in mid luteal previous cycle (21 cycle) for 10 days. Cetrotide (Cetrorelix, Switzerland) 0.25 sub cutaneous daily is administered after cessation of estradiol. Cetrotide is continued for 7 days and ovarian stimulation is started after 7 days of GnRH antagonist pretreatment with 300 unit gonadotropin(Gonal f, Sorono, Switzerland).The women are controlled with serial sonography after five day ovarian stimulation. When a lead follicle reaches 12 millimeter, Cetrotide is initiated again and is continued until the human chorionic gonadotropin ( HCG, Pregnyle,Netherlands ) trigger. Final oocyte maturation is triggered in both groups with 10,000 unit HCG when the largest two follicles attain a mean diameter of 17 millimeter. Oocyte retrieval is performed under transvaginal ultrasound guidance 36 hours after hCG administration
Category
Treatment - Drugs
2
Description
In control group, microdose flare Gn RH agonist protocol for controlled ovarian hyperstimulation is used.On the second day of menstrual cycle Buserlin acetate (Cinnafact, Cinnagen) 50 micro gram twice daily sub cutaneous is initiated which continued until trigger day. After 2 days, stimulation with a gonadotropin (Gonal f, Sorono,Switzerland) 300 unit daily is begun. The women are controlled with serial sonography since 9th day of cycle.The dose and follow up are individualized according to the ovarian response. Final oocyte maturation is triggered with 10,000 unit human chorionic gonadotropin (HCG,Pregnyle, Netherlands) when the largest two follicles attain a mean diameter of 17 millimeter. Oocyte retrieval is performed under transvaginal ultrasound guidance 36 hours after hCG administration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences
Full name of responsible person
DR Robab Davar
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
DR Robab Davar
Street address
Bahonar square, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences
Full name of responsible person
DR Nosrat Neghab
Position
Obstetrician and gynecologist fellowship of infertility and IVF (studying)
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
nosrat20@yahoo.com; nosratneghab@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences
Full name of responsible person
DR Robab Davar
Position
Obstetrician and gynecologist fellowship of infertility and IVF associated professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
davar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences
Full name of responsible person
DR Nosrat Neghab
Position
ObstetricIan and gynecologist fellowship of infertility and IVF(studying)
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
nosratneghab@ssu.ac.ir; nosrat20@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)