The effect of luteal phase support by a progestogen drug (cyclogest)on pregnancy rates of stimulated IUI cycles of 98 infertile couples (study group) with unexplained infertility that were compaired with stimulated IUI cycles of 102 infertile couples (control group) without drug taking for luteal phase support
Two- hundred couples , who refered toMirza koochak khan Hospital with unexplained infertility(UEI) ,who underwent 511 consecutive stimulated IUI cycles.Clomiphene citrate (c.c) and human Menopausal Gonadotropin (h M G) were used for ovulation induction.Inclusion criteria:infertile women with UEI / normal semen analysis based on World Health Organization criteria /normal early follicular phase ultrasound / normal FSH and LH (<10 IU/L), midluteal phase serum P >20 nmol/L/patent tubes and normal uterine cavity confirmed with hysterosalpingography. The patients were excluded from the study if the female partners had age> 36 years old, diminished ovarian reserve (basal FSH level>10 IU/ L), one ovary, polycystic ovaries on ultrasound examination, previous surgery on ovaries, endometriosis and any type of endocrine disease. After IUI, the patients were randomized into the two groups. The study group (n=98) received intra vaginal P (Cyclogest) for LPS. The patients randomized into the control group (n=102) received no drug for LPS.Main outcome Measures are Clinical Pregnancy rate (PR) and live birth rate (BR) per cycle and patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901283737N1
Registration date:2010-04-28, 1389/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-28, 1389/02/08
Registrant information
Name
Mahbod Ebrahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 7761
Email address
maebrahimi@rasi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University/Mirza koochak khan Hospital
Expected recruitment start date
2007-09-01, 1386/06/10
Expected recruitment end date
2008-11-29, 1387/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of luteal phase support by a progestogen drug (cyclogest)on pregnancy rates of stimulated IUI cycles of 98 infertile couples (study group) with unexplained infertility that were compaired with stimulated IUI cycles of 102 infertile couples (control group) without drug taking for luteal phase support
Public title
Increase in pregnancy rate of infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:infertile couples with unexplained infertility / normal semen analysis based on World Health Organization criteria /normal early follicular phase ultrasound / normal FSH and LH (<10 IU/L), midluteal phase serum P >20 nmol/L/patent tubes and normal uterine cavity confirmed with hysterosalpingography. The unexplained infertile patients were excluded from the study if the female partners had age> 36 years old, diminished ovarian reserve (basal FSH level>10 IU/ L), one ovary, polycystic ovaries on ultrasound examination, previous surgery on ovaries, endometriosis and any type of endocrine diseases.
Age
From 18 years old to 36 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Tehran Medical Science University
Street address
Pour sina Ave/ Tehran
City
Tehran
Postal code
00982188915959
Approval date
empty
Ethics committee reference number
222
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
pregnancy rate
Timepoint
monthly
Method of measurement
pregnancy rate persentile/ pregnancy will be confirmed by serum sample test
Secondary outcomes
1
Description
live birth rate
Timepoint
9 months
Method of measurement
live birth rate persentile in each groups
Intervention groups
1
Description
in study group:Cyclogest/400 mg every night/in luteal phase/ if pregnancy happen, this drug will continue till 10 weeks/ if pregnancy does not happen, the drug will continue till14 nights.
Category
Treatment - Drugs
2
Description
in control group: no drug receiving in luteal phase.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirza koochak khan Hospital
Full name of responsible person
Mahbod Ebrahimi.M.D
Street address
Ostad Nejatollahi Ave/ Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Medical Sciences University
Full name of responsible person
Firoozeh AkbariM.D
Street address
Pour sina Ave/ Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Medical Sciences University
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 Medical Sciences University
Full name of responsible person
Firoozeh Akbari M.D
Position
Faculty member
Other areas of specialty/work
Street address
Ostad Nejatollahi Ave/Mirza Koochak Hospital/ Tehran
City
Tehran
Postal code
1597856511
Phone
+98 21 8889 7761
Fax
+98 88915959
Email
f.asbagh@razi.tums ac ir/maeb214@yahoo.com/f. asbaghM.D@yahoo.com