Our objective was to assess the efficacy of luteal phase support with progesterone suppository in women undergoing IUI cycles.
A total of 100 couples who were undergoing IUI treatment. Ovulation induction was done for all patients. After IUI patients were randomized into two groups. The study group (n=50) received progesterone suppository and control group (n=50) received no medicine. The main outcome was the comparison of biochemical and clinical pregnancy rate, abortion rate and suppository side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041233379N1
Registration date:2017-05-15, 1396/02/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-15, 1396/02/25
Registrant information
Name
Majid Rajaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3826 8887
Email address
dr.rajaee@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
individual
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progesterone suppository to luteal phase support on pregnancy rates in the intrauterine insemination cycles
Public title
The effect of progesterone on pregnancy rates in the intrauterine insemination cycles
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:normal sonograph;normal fsh , lh @AMH;without cardiac, pulmonary and renal disease;mild endometriosis;normal sperm analysais;normal HSG and exclusion criteria:more than 36 years old;previous ovarian surgery;tubal factor;severe endometriosis; Hypothalamic Amenorrhea ;Endocrine causes of infertility and amenorrhea;patients with more than 3 Follicles with 14 mm diameters;sever oligoasthenospermia
Age
To 36 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Shahid Sadoughi University of Medical Science
Street address
Shahid Bahonar sq.
City
Yazd
Postal code
Approval date
2015-03-21, 1394/01/01
Ethics committee reference number
IR@SSU.MEDICINE.REC.1394.425
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
2
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
16 days
Method of measurement
beta HCG>50 milli-international units per milliliter (mIU/ml)
2
Description
clinical pregnancy
Timepoint
6 weeks
Method of measurement
gestational sac in sonography
Secondary outcomes
1
Description
abortion
Timepoint
20 weeks
Method of measurement
loss of pregnancy before 20 weeks
2
Description
side effects
Timepoint
9 months
Method of measurement
patient
Intervention groups
1
Description
All cycles were gently stimulated after baseline
transvaginal ultrasonography
with 100 mg oral
tablets of clomiphen citrate
daily for 5 days starting on
day 3 of the menstrual cycles and a starting
dose of 150 IU human menopausal gonadotropin
on days 8-11
of the cycles. All patients were re-evaluated by
ultrasound on day 11 for quality of the ovarian
response, which was repeated every 2-3 days.
The dosage of hMG was adjusted according to
the ovarian response. Stimulation continued until
one to three follicles reached a mean diameter
of 18 mm, then 10000 IU hCG
was administered and the
single IUI was performed 34-36 hours later. The
experimental group received progestrone vaginal
Suppository 400 mg daily for luteal support
. If the patient conceived, luteal support
was continued through the tenth week of pregnancy.Serum hCG was obtained 2 weeks after
hCG administration and intrauterine pregnancy
was confirmed by detection of a gestational sac
using transvaginal ultrasound 6 weeks after insemination.
A clinical pregnancy was defined as
the presence of a gestational sac on ultrasound
or by histological examination of products of
conception in patients who aborted.
Category
Treatment - Drugs
2
Description
control group received no medicine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research-Clinical Center of Infertility
Full name of responsible person
Maryam Yasaei
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Individual
Full name of responsible person
Maryam Yasaei
Street address
15 Khordad Ave,Shohadaie mehrab sq.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Individual
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
Shahid Sadoughi University of Medical Science
Full name of responsible person
Maryam Yasaei Mehrjardi
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Shahid Bahonar sq.
City
Yazd
Postal code
Phone
+98 35 3724 0171
Fax
Email
info@ssu.ac.ir
Web page address
ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Razieh Dehghani Firozabadi
Position
Obstetricians & gynecologist
Other areas of specialty/work
Street address
Shahid Bahonar sq.
City
Yazd
Postal code
Phone
+98 35 3724 0171
Fax
Email
info@ssu.ac.ir
Web page address
ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi Unversity of Medical Science
Full name of responsible person
Maryam Yasaei
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Shahid Bahonar sq.
City
Yazd
Postal code
Phone
+98 35 3724 0171
Fax
Email
info@ssu.ac.ir
Web page address
ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)