A comparison of Dual triggering by administration of Gonadotropin releasing hormon agonist plus human chorionic gonadotropin versus HCG in normal responders at assisted reproductive programs outcome
The aim of this study was to evaluate the effect of dual triggering in Art outcome.210 patients began ovarian stimulation with a flexible starting
dosage of recombinant FSH (Gonal-F; Merck Serono .)
ranging from 150 to 225 IU on the second day of the menstrual cycle for 5 consecutive days. Once the leading follicle had reached a size of 13 mm,
co-treatment with the GnRH antagonist 0.25 mg/day, was initiated. Gonadotropins doses were further adjusted according to vaginal ultrasound measurements of follicular diameter,obtained every two or three days. When at least two leading follicles had reached 17 mm in diameter, final oocyte maturation was
triggered by either 6500 I.U. hCG alone, or by 6500 IU hCG plus 0.2 mg of triptorelin (Decapeptyl; Ferring GmbH).Oocyte retrievals were performed under transvaginal ultrasound guidance 34 to 36 hours after triggering. All embryo transfers were performed 48 to72 hours after oocyte retrieval.
The luteal phase was supported by daily progesterone suppositories(total dose 800mg) starting on the day of oocyte retrieval. Serum b-hCG was measured 14 days after transfer, and a value above 5 IU/mL was considered
to be a positive pregnancy. The luteal support was then
continued until the 10th week of gestation.The primary outcome measure was clinical pregnancy rate and the secondary outcome measures were implantation rate,chemical pregnancy , ongoing pregnancy ,OHSS rate andf abortion rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031221420N2
Registration date:2015-06-25, 1394/04/04
Registration timing:retrospective
Last update:
Update count:2
Registration date
2015-06-25, 1394/04/04
Registrant information
Name
Maryam Farid Mojtahedi
Name of organization / entity
Arash women hospital,clinic for infertility,Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
m_fmojtahedi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd reserch and clinical center for infertility
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of Dual triggering by administration of Gonadotropin releasing hormon agonist plus human chorionic gonadotropin versus HCG in normal responders at assisted reproductive programs outcome
Public title
Dual triggering in improving assisted reproductive programs outcome
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were tubal or male infertility; BMI < 30;age ≤ 42 years;absence of major endocrinologal pathology; first, second and third IVF cycle.
Exclusion critera was:azoospermia; high or poor response to controlled ovarian hyperstimulation (COH).;Poor ovarian response was defined as serum estradiol (E2) level less than 500 pg/mL on the day of triggering or the number of retrieved oocytes less than 3. High ovarian response was defined as an E2 level greater than 3,000 pg/mL on the day of triggering or the number of retrieved oocytes more than 15. Other exclusion criteria were age above 42; body mass index <18 or >30 kg/m2; day-3 follicle stimulating hormone (FSH) concentration ≥10 IU/L or serum antimullerian hormone (AMH) ≤1.0 ng/mL);presence of endocrine disorders such as diabetes mellitus;hyperprolactinemia;thyroid disorders; congenital adrenal hyperplasia;Cushing syndrome; or polycystic ovary syndrome;Congenital uterine anomalies
Age
To 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
891687391
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
315
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 rate
Timepoint
28 days after transfer
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
chemical pregnancy rate
Timepoint
14 days after transfer
Method of measurement
BhCG test
Intervention groups
1
Description
control group receive 6500 I.U hCG IM for triggering final oocyte maturation .
Category
Treatment - Drugs
2
Description
Intervention group receive 6500 I.U. IM hCG+triptorelin0.2mg/sc for triggering.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Avenue, Safayeh
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali Avenue, Safayeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Alimohammad Abdoli
Street address
Bouali Avenue, 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 reaserch 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
Yazd reaserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
assisted proffesor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 38247087
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
assisted proffesor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Maryam Farid Mojtahedi
Position
Infertility fellowship
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
m_fmojtahedi@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)