The effect of progesterone supplementation on pregnancy rates in controlled ovarian stimulation and intrauterine insemination cycles: a randomized prospective trial
The aim of this study was to evaluate the effect of vaginal progesterone as a luteal phase support on pregnancy rates in controlled ovarian hyper stimulation and intrauterine insemination cycles in couples with unexplained infertility or mild male factor infertility. This prospective randomized controlled trial was performed at the Shariati University Hospital, Tehran, Iran and private practice setting, Omid clinic and included 290 patients, who met the inclusion criteria. All the patients were undergone controlled ovarian hyper stimulation and intrauterine insemination. Men had at least two normal semen analyses before any treatment. 142 patients were randomized to start with a supported cycle and 148 patients started with an unsupported cycle. In supported cycles, the patients received vaginal progesterone once daily from the day after insemination until 12 weeks of pregnancy, and in non pregnant women for 14 days. No progesterone was given during unsupported cycles. The main outcome measures were clinical pregnancy rates per cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104266292N1
Registration date:2011-05-31, 1390/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-31, 1390/03/10
Registrant information
Name
Mahboobe Rahmani
Name of organization / entity
Tehran University of Medical Science, Shariati Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2414
Email address
rahmani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progesterone supplementation on pregnancy rates in controlled ovarian stimulation and intrauterine insemination cycles: a randomized prospective trial
Public title
The effect of progesterone supplementation on pregnancy rates in controlled ovarian stimulation and intrauterine insemination cycles: a randomized prospective trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All women included in the study were between the age 18 and 35 years and BMI of 18-28 kg/m2, regular mense, and no PCOD (according to Rotterdam criteria), basal FSH<10 IU/L and normal serum prolactin level and normal thyroid function. All couples had been trying unsuccessfully to conceive for at least one year before being enrolled in the trial. All women had bilateral tubal patency and normal uterine cavity, confirmed by hysterosalpinography (HSG), performed a maximum of 6 months before the start the stimulation. Men had at least two semen analyses before any treatment. Normal semen analysis were defined by the threshold values of the World Health Organization criteria, ≥4% sperm had normal morphology according to the criteria of Kruger et al, or total motile sperm count ≥ 1 million following semen preparation
Exclusion criteria: abnormal prolactin serum level and abnormal thyroid function test, polycystic ovary syndrome according to Rotterdam criteria, diminished ovarian reserve (basal FSH level >10 IU/mL, presence of resistant ovarian cyst (>20mm for > 1 months), hypogonadotrophic hypogonadism or any contraindications for progesterone therapy
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods Street
City
Tehran
Postal code
Approval date
2011-05-09, 1390/02/19
Ethics committee reference number
و/210/1434/90
Health conditions studied
1
Description of health condition studied
Female infertility, unspecified
ICD-10 code
N97.9
ICD-10 code description
inability to achieve a pregnancy
2
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Azoospermia NOS
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
4 weeks after insemination
Method of measurement
Transvaginal sonography
Secondary outcomes
1
Description
Ovulation rate
Timepoint
The days 12, 14 cycles
Method of measurement
Transvaginal sonography
Intervention groups
1
Description
Intervention: application of progesterone 400 mg vaginal suppository Cyclogest once daily from the day of IUI until negative beta HCG or 12 week
Category
Treatment - Drugs
2
Description
Controi: no drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital, Infertility Center
Full name of responsible person
Mahboobeh Rahmani
Street address
Gisha Brd, Amirabad Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Marzieh Aghahosseini
Street address
Gisha Brd, Amirabad Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Science, Shariati Hospital
Full name of responsible person
Mahboobeh Rahmani
Position
Resident of OB & GYN
Other areas of specialty/work
Street address
Gisha Brd Amirabad Ave
City
Tehran
Postal code
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
rahmani@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science, Shariati Hospital
Full name of responsible person
Mahboobeh Rahmani
Position
Resident of OB & GYN
Other areas of specialty/work
Street address
Gisha Brd, Amirabad Ave
City
Tehran
Postal code
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
rahmani@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science, Shariati Hospital
Full name of responsible person
Mahboobeh Rahmani
Position
Resident of OB & GYN
Other areas of specialty/work
Street address
Gisha Brd, Amirabad Ave
City
Tehran
Postal code
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
rahmani@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)