Frozen Thawed Embryo Transfer Cycles: A Comparison of Pregnancy Outcomes with and without Prior Pituitary Suppression by Gonadotropin-releasing hormone Agonists
1-Objectives: Our study is aimed at evaluating the pregnancy outcome rate of Frozen thawed embryo transfer (FTET) with and without GnRH agonists pretreatment.
2-Design:This experiment is designed as a randomized controlled trial in a population of southern Iranian women with documented infertility.
3-Setting and Conduct: Women with documented infertility who were candidate for FTET were studied in a one year period from November 2012 to November 2013. Study population were randomly assigned to two groups, 100 patients in each group.
4-Participants including major eligibility criteria: couples with documented infertility of any cause with the women being 20-39 years, who had frozen embryo available for transfer entered the study.
5-Intervention: In group A,patients received GnRH agonist, Busereline, to induce pituitary desensitization prior to endometrial preparation and embryo transfer. Individuals in the group B received steroid manipulation without prior downregulation of the pituitary.
6-Main outcome measures: Short term outcomes including chemical pregnancy (defined as βHCG level > 10 IU per L obtained 16 days after Frozen Thawed Embryo Transfer ), clinical pregnancy (intrauterine gestational sac daring ultrasound examination 5weeks after transfer date), ongoing pregnancy rates (presence of intrauterine fetal heart motion 12 weeks after transfer date) along with implantation rate (number of gestational sacs with fetal pole detected) were measured and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052834184N1
Registration date:2017-08-07, 1396/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
Golnaz Namazi
Name of organization / entity
Harvard University
Country
United States
Phone
0018572704661
Email address
gnamazi@partners.org
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences grants No 5665.
Expected recruitment start date
2012-11-01, 1391/08/11
Expected recruitment end date
2013-11-01, 1392/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Frozen Thawed Embryo Transfer Cycles: A Comparison of Pregnancy Outcomes with and without Prior Pituitary Suppression by Gonadotropin-releasing hormone Agonists
Public title
comparison between pregnancy outcome of in vitro fertilization (assisted reproductive technology ) with and without Gonadotropin-releasing hormone agonist
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
Documented infertility of any cause;Aged 20-39 years; Couples undergoing ART with their own gametes;Women stimulated with a long GnRH agonist protocol of IVF (for group A);Couples having frozen embryo available for transfer
exclusion criteria:
Age > 39 years; High grade endometriosis;Existence of myoma or adhesion in uterus;Body mass index (BMI) more than 29 kg/m2 or less than 18 kg/m2;Oocyte donation cycles
Age
From 20 years old to 39 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Ethical Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand ST,
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
5665
Health conditions studied
1
Description of health condition studied
in vitro fertilization
ICD-10 code
Z31.2
ICD-10 code description
Admission for harvesting or implantation of ova
2
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
inability to achieve a pregnancy
Primary outcomes
1
Description
pregnancy outcome
Timepoint
since 16 days post transfer until delivery
Method of measurement
beta hCG, Ultrasound
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
5 weeks after transfer date.
Method of measurement
observation of intrauterine gestational sac during ultrasound examination 5 weeks after transfer date.
2
Description
chemical pregnancy
Timepoint
16 days following thawed embryo transfer
Method of measurement
Serum βHCG level > 10 IU per L
3
Description
Ongoing pregnancy
Timepoint
12 weeks after transfer date
Method of measurement
presence of intrauterine fetal heart motion
4
Description
implantation rate
Timepoint
9 weeks post transfer
Method of measurement
number of gestational sacs with fetal pole detected using vaginal ultrasound to the number of transferred embryos
5
Description
Miscarriage rate
Timepoint
under the 20th week of gestation
Method of measurement
ultrasound and beta hCG
Intervention groups
1
Description
Participanpatients in group A received GnRH agonist prior to ovulation induction.0.5 mg of Busereline acetate (a GnRH agonist) (Suprefact, Hoechst AG, Germany) was injected subcutaneously daily starting on the 21st day of menstrual cycle (mid luteal phase). On the first day of menstruation, GnRH agonist dose was reduced to 0.3 mg SC per day.
Category
Treatment - Drugs
2
Description
patients in group B had steroid manipulation and routine IVF regimen without prior down-regulation of the pituitary
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz ghadir Mother and child subspecialized hospital
Full name of responsible person
Zohre Chitsazi
Street address
Mother and Child Hospital Ghadir, above gate Quran, First Town Gulshan
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor of research Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Shiraz University of Medical sciences, vice chancellor of research,Zand Blvd
City
Shiraz
Grant name
Grant code / Reference number
۵۶۶۵
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor of research Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zohre Chitsazi
Position
Obstetrics and Gynecology resident, Doctor of medicine
Other areas of specialty/work
Street address
Ob/Gyn department office, Shahid Faghihi Hospital,Zand St
City
Shiraz
Postal code
Phone
+98 917 714 4835
Fax
Email
z.chitsazi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohre Chitsazi
Position
Ob Gyn resident, M.D
Other areas of specialty/work
Street address
Ob/Gyn department office, Shahid Faghihi hospital,,Zand st
City
Shiraz
Postal code
Phone
+98 917 714 4835
Fax
Email
z.chitsazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Golnaz Namazi
Position
M.D
Other areas of specialty/work
Street address
393 Broadway ,Apt 27
City
Cambridge
Province
Massachusetts
Postal code
02139
Phone
00
Fax
+987136293620
Email
golnaznamazi25@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)