Objective: We design this study in order to assess adding human chorionic gonadotropin (HCG) to the conventional protocol in endometrial preparation in women with thin endometrium and a history of in vitro fertilization–embryo transfer (IVF-ET) failure.
Design: 28 infertile women with thin endometrium are studied in this non-randomized clinical trial study (quasi experimental design) from September 2013 تا January 2014.
Inclusion and Exclusion criteria:Infertile women who are candidate for frozen-thawed (ET) with at least 2 previous failed IVF cycle, thin endometrium (thickness less than 7 mm) despite conventional treatment in previous IVF cycles (vaginal estrogen, sildenafil, vitamin E, ...). Patients with intrauterine lesion such as sub mucosal leiomyoma, history of endometriosis, and thyroid disorders are excluded.
Intervention: All the patients receive 8 mg estradiol valterate valerate from the second day of menstrual cycle and continued at least for seven days. HCG (Pregnyl®, Darou Pakhsh, Iran) are administrated (150 IU, IM) from the 8th day of cycle. On the 12-13th day Trans-vaginal sonography are done and endometrial thickness are measured. If it are proper, (at least 7mm) HCG stop and after 24 h progesterone 100 mg intramuscular are injected for 3 days. Finally, ET are performed.
Main outcome measures: The pregnancy test (serum βHCG) was done two weeks after ET. Fetal heartbeat (clinical pregnancy) was checked after 2-3 weeks after positive βHCG test .
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201512082604N2
Registration date:2016-01-14, 1394/10/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-14, 1394/10/24
Registrant information
Name
Robab Davar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
davar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2015-01-01, 1393/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adding human chorionic gonadotropin to frozen thawed embryo transfer cycles in women with history of thin endometrium: A clinical trial
Public title
Effect of adding human chorionic gonadotropin to frozen thawed embryo transfer cycles with history of thin endometrium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile women who are candidate for frozen-thawed (ET); with at least 2 previous failed IVF cycle, thin endometrium (thickness less than 7 mm) despite conventional treatment in previous IVF cycles (vaginal estrogen; sildenafil; vitamin E; ...).
Exclusion criteria: Oocyte donation; Endometriosis; Polycystic Ovary Syndrome; Intrauterine lesion such as submucosal leiomyoma; history of endometriosis; and thyroid disorders.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Research and Clinical Center for Infertility, Shahid Sadoughi University of Med
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safaeyeh,Yazd, Iran.
City
Yazd
Postal code
8916877391
Approval date
2014-06-23, 1393/04/02
Ethics committee reference number
317
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
2-3 weeks after positive pregnancy test
Method of measurement
Fetal heartbeat after 2-3 weeks.
2
Description
Chemical pregnancy
Timepoint
2 weeks after emberyo transfer
Method of measurement
serum βHCG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All the patients receive 8 mg estradiol valterate valerate from the second day of menstrual cycle and continued at least for seven days. HCG (Pregnyl®, Darou Pakhsh, Iran) are administrated (150 IU, IM) from the 8th day of cycle. On the 12-13th day Trans-vaginal sonography are done and endometrial thickness are measured. If it are proper, (at least 7mm) HCG stop and after 24 h progesterone 100 mg intramuscular are injected for 3 days. Finally, ET are performed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Robab Davar
Street address
Research and Clinical Center for Infertility, Bouali Ave., Safaeyeh, Yazd, Iran.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Shahid Sadoughi University of Medical Sciences,Yazd, Iran.
Full name of responsible person
Dr. Robab Davar
Street address
Research and Clinical Centerfor Infertility, Bouali Ave, Safaeyeh,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,Yazd, Iran.
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 Centerfor Infertility, Shahid SadoughiUniversity of Medical Sciences,Bouali Av
Full name of responsible person
Dr. Robab Davar
Position
Gynocologist/Infertility Fellowship (M.D.)/ Associated Professor of Shahid Sadoughi University of me
Other areas of specialty/work
Street address
Yazd Research and Clinical Centerfor Infertility, Bouali Ave, Safaeyeh, Yazd, Iran.
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
r_davar@yahoo
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, School of Medicine, Shahid Sadoughi University of Medi
Full name of responsible person
Dr. Robab Davar
Position
Gynocologist/Infertility Fellowship (M.D.)
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, School of Medicine, Shahid Sadoughi University of Medical Sciences, Bouali Ave, Safaeyeh,Yazd, Iran
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
r_davar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd,
Full name of responsible person
Dr. Robab Davar
Position
Gynocologist/Infertility Fellowship (M.D.)
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safaeyeh, Yazd, Iran.
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
r_davar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)