Objective: Comparison of oral dydrogesterone with vaginal cyclogest for luteal support in IUI cycles. Design: A randomized multicenter clinical trial. Setting and conduct and participants including major eligibility criteria: 150 women younger than 35 years old with unexplained infertility, Proper ovulation, 2 open tubal, Not having severe or moderate problem of man and without a history of previous abdominal surgery were included in this study. Informed consent was obtained from all patients. All women received a daily 75 IU FSH and they underwent ultrasonography on 8-9 days of the menstrual. In patients who had 3-4 follicles with a diameter of more than 18 mm, HCG to release oocytes was injected and IUI was performed 36 hours later. 2 days after IUI, Patients randomly were divided in two groups: Group A or oral dydrogesterone group (n=75) and group B or vaginal cyclogest group.Group A received 10 mg dydrogesterone twice per day and group B received 400 mg vaginal progesterone once per night. Progesterone administration was continued until 12 weeks of pregnancy. Finally, Pregnancy rates, Abortion rates, Serum levels of progesterone (on day 21 of the menstrual cycle; 7 days after IUI) and patient satisfaction in both groups were compared. Main outcome measures: Clinical pregnancy rate. Second outcomes measures: Progestrone serum level and miscarriage rates and patient acceptance.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010220408N2
Registration date:2015-01-18, 1393/10/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-18, 1393/10/28
Registrant information
Name
Robabeh Taheripanah
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
taheripanahf@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Science
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral dydrogesterone with vaginal cyclogest for luteal support in IUI cycles
Public title
progestrone effect on pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; Women younger than 35 years old with unexplained infertility; Proper ovulation; 2 open tubal; Not having severe or moderate problem of man and without a history of previous abdominal surgery. Exclusion criteria; Advanced endometriosis; Dense pelvic adhesion; Genital TB; Patients who did not reffer for following up.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Infertility & Reproductive Health Research Center Ethics committee of Shahid Beheshti University of