Background: Management of poor responders to ovarian stimulation who encompass about 9-18% of the patients undergoing IVF, is the most difficulties in assisted reproductive techniques (ART). Objective: The present study focused on the use of ultrashort GnRH agonist in antagonist protocol and microdose GnRH agonist flare-up in poor responders to ovarian induction.
Materials and Methods: One hundred and twenty candidates of ART that referred to Yazd Research and Clinical Center for Infertility (From June 2007 to July 2009) who had a history of one or more failed IVF cycles with three or fewer retrieved oocytes, were prospectively randomized in two groups. In group I (60 patients), the microdose flare-up regimen and in group II (60 patients), the ultrashort GnRH agonist combined with fixed GnRH antagonist were used. Main outcomes measures included: the number of follicles and oocytes, endometrial thickness, clinical and chemical pregnancy and implantation rates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105096420N1
Registration date:2011-06-06, 1390/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-06, 1390/03/16
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2007-06-21, 1386/03/31
Expected recruitment end date
2009-06-21, 1388/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between ultrashort gonadotropin-releasing hormone agonist and flare microdose protocol in ART poor responders
Public title
Comparison of two treatment protocol in assisted reproductive techniques (ART) poor responders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: A history of one or more failed in IVF cycles which three or fewer oocytes were been retrieved or their serum steradiol’s level in day of HCG injection was <500 pg/ml or FSH in day 3 of cycle was >10 or age>40 years. Exclusion criteria: Body mass index higher than 30 and endocrine or metabolic disorder, endometriosis and severe male factor (azospermia ).
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Research and Clinical Center for Infertility
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
8916877391
Approval date
2009-01-05, 1387/10/16
Ethics committee reference number
2421
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy
Timepoint
2 weeks
Method of measurement
BhcG Test
Secondary outcomes
1
Description
number of follicles
Timepoint
15 days
Method of measurement
Numbering
2
Description
quality of oocytes
Timepoint
15 days
Method of measurement
Observation by microscope according to Good –postmature-degenerated
3
Description
the number of used gonadotropin ampoules
Timepoint
15 days
Method of measurement
Numbering
4
Description
Quality of emberyo
Timepoint
15 days
Method of measurement
According to the symmetrics and exact of Blastomer pieces
5
Description
Number of oocytes
Timepoint
15 days
Method of measurement
Numbering
6
Description
Chemical pregnancy
Timepoint
after 14 days of embryo transfer
Method of measurement
Measurement of serum B-hCG
7
Description
Clinical pregnancy
Timepoint
2-3 weeks after positive B-hCG
Method of measurement
observation of the fetal heart activity using a transvaginal ultrasonography
Intervention groups
1
Description
In group I, 0.05mg subcutaneous Buserelin (suprefact, serono) was injected two times per day from the day 1 of cycle and HMG (Menogon, Ferring) 300 IU per day intramuscular from day 3 of cycle. Follicular monitoring was started from day 9 of cycle by serial vaginal ultrasonography and then gonadotropin doses adjustment was done as required. hCG (pregnyl; NV organon, oss, Netherlands) 10000 IU was injectod Intramuscular when at least 2 follicles ≥ 18mm were noted on ultrasonography. Oocyte retrieval was scheduled 36 hours after hCG injection and conventional IVF or intracytoplasmic sperm injection (ICSI) was performed. Embryo transfer was done 48-72 hours after oocyte retrieval. The luteal phase support was initiated from the day of oocyte retrieval with 100 mg Progesterone in oil (Progesterone, Abureihan co., Tehran, Iran) per day.
Category
Treatment - Drugs
2
Description
In group II, ovulation induction was performed with Buserelin (suprefact, serono) 0.5mg SC per day started on day 1 of cycle and continued for 3 consecutive days . HMG (menogon, ferring) 300 IU per day was started on day 3 of cycle. GnRH antagonist (cetrorelix, serono laboratories, Aubonne, Switzerland) 0.25mg sc per day was started when the follicle’s size reach to 14mm. Follicular monitoring started from day 9 of cycle and hCG (pregnyle, NV orgaron, oss, Nether lands) 10000 IU was injected if at least 2 follicles ≥ 17-18mm were noted on ultrasonography and Oocyte retrieval was scheduled 36 hours after hCG injection. Other steps was done like group I. In both groups, Serum B-hCG was measured after 14 days of embryo transfer. If B-hCG was Possitive, the clinical pregnancy was confirmed by observation of the fetal heart activity using a transvaginal ultrasonography 4-5 weeks after oocyte retrieval. And thenو the two groups were compared in number of follicles, serum estradiol levels, endometrial thickness, Number and quality of oocytes, number and quality embryo, implantation rate and clinical and chemistry pregnancy rate.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Dr. Maryam Eftekhar
Street address
Boali Ave., Safayeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Dr. Abbas Aflatoonain
Street address
Bouali Ave, Safayeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Research and Clinical Center for Infertility
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
Research and Clinical Center for Infertility
Full name of responsible person
Dr. Maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
yazd Research and Clinical Center for Infertility, Bouali Ave, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7348
Fax
+98 35 1824 7087
Email
eftekhar@ssu.ac.ir , pkhani55@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Maryam Eftekhar
Position
M.D.
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 8348
Fax
+98 82 47087
Email
eftekhar@ssu.ac.ir , pkhani55@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Research and Clinical Center for infertility
Full name of responsible person
Dr. Maryam Eftekhar
Position
M.D.
Other areas of specialty/work
Street address
Yazd Research and Clinical Center for infertility, Safayeh, Boali Ave.
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 8348
Fax
+98 35 1824 7087
Email
eftekhar@ssu.ac.ir , pkhani55@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)