Objective: to compare oral dydrogestrone with vaginal progesterone for luteal-phase support in IVF.
Materials and methods: We performed this prospective, randomized double-blind trial in a tertiary infertility care unit in Taleghani hospital, Tehran, Iran. inclusion criteria: Women with a history of male factor infertility, euthyroid and normoprolactinemic. undergoing controlled ovarian stimulation for IVF treatment (fresh cycle) were included in this study.
exclusion criteria: Women with tubal factor, idiopathic infertility, endometriosis-related infertility and ovulatory disturbances, moreover, women with baseline FSH >12 IU and adenomyosis ,endometriosis, myoma and chronic hepatorenal disease were excluded.
80 Women with a history of male factor infertility undergoing controlled ovarian stimulation for IVF treatment (fresh cycle) randomly were divided in two groups (group A or oral dydrogesterone group and group B or vaginal cyclogest group)
Group A (n =40) received 10 mg dydrogesterone QID (40mg daily) and group B (n =40) received 400 mg vaginal Progesterone (cyclogest) twice per day (800 mg daily).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050713265N1
Registration date:2013-06-22, 1392/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-22, 1392/04/01
Registrant information
Name
Maryam Tamimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
maryamtamimi@ymail.com
Recruitment status
Recruitment complete
Funding source
this study is supported financially by the Infertility and Reproductive Health Research Center (IRHRC),Shahid Beheshti University of Medical Sciences.
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral dydrogestrone with vaginal progesterone for luteal-phase support in IVF
Public title
Comparison of oral dydrogestrone with vaginal progesterone
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
clinical pregnancy
Timepoint
six weeks following intervention
Method of measurement
sonography and pregnancy test
2
Description
abortion
Timepoint
six weeks following intervention
Method of measurement
sonography and pregnancy test
Secondary outcomes
1
Description
luteal-phase duration
Timepoint
2 weeks following intervention
Method of measurement
patient history
Intervention groups
1
Description
group A: received 10 mg dydrogesterone QID (40mg daily) began on the day of oocyte retrieval and was continued up to 12 weeks of pregnancy.
Category
Treatment - Drugs
2
Description
group B: received 400 mg vaginal Progesterone twice per day (800 mg daily) began on the day of oocyte retrieval and was continued up to 12 weeks of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and Reproductive Health Research Center,Shahid Beheshti University of Medical Sciences,T
Full name of responsible person
Dr. Saghar Salehpour
Street address
: Infertility and Reproductive Health Research Center (IRHRC), IVF center,Shahid Beheshti University of Medical Sciences, Tehran, Iran, Taleghani hospital, Parvaneh st, Yaman st,Velenjak st, Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Infertility and Reproductive Health Research Center (IRHRC), IVF center,Shahid Beheshti University o
Full name of responsible person
Dr. Saghar Salehpour
Street address
Infertility and Reproductive Health Research Center (IRHRC), IVF center,Shahid Beheshti University of Medical Sciences, Tehran, Iran, Taleghani hospital, Parvaneh st, Yaman st,Velenjak st, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Infertility and Reproductive Health Research Center (IRHRC), IVF center,Shahid Beheshti University o
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
Infertility and Reproductive Health Research Center (IRHRC), IVF center,Shahid Beheshti University o
Full name of responsible person
Dr. Saghar Salehpour
Position
Associate professor in OBGYN/IVF fellowship- chief of Taleghani hospital IVF center
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Tehran, Iran, Taleghani hospital, Parvaneh st, Yaman st,Velenjak st, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2243 2558
Fax
Email
saghar.salehpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility and Reproductive Health Research Center (IRHRC),Shahid Beheshti University of Medical Sc
Full name of responsible person
Dr. Saghar Salehpour
Position
Associate professor in OBGYN/IVF fellowship
Other areas of specialty/work
Street address
: Infertility and Reproductive Health Research Center (IRHRC), IVF center,Shahid Beheshti University of Medical Sciences, Tehran, Iran, Taleghani hospital, Parvaneh st, Yaman st,Velenjak st, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2243 2558
Fax
Email
saghar.salehpour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
: Infertility and Reproductive Health Research Center (IRHRC), IVF center,Shahid Beheshti University
Full name of responsible person
Dr. Maryam Tamimi
Position
Gynecologist/Resident of IVF fellowship
Other areas of specialty/work
Street address
: Infertility and Reproductive Health Research Center (IRHRC), IVF center,Shahid Beheshti University of Medical Sciences, Tehran, Iran, Taleghani hospital, Parvaneh st, Yaman st,Velenjak st, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2243 2558
Fax
Email
maryamtamimi@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)