Clinical pregnancy outcomes of controlled ovarian stimulation with recombinant-FSH plus recombinant-LH versus human Menopausal Gonadotropin plus recombinant-FSH has become the object of interest.
This is a randomized clinical trial study held among 140 patients referring to infertility clinic in valiasr hospital between 2014 -2016. Patients enrolled in this study according to a set of inclusion criteria (aged 20-35 years, Tubal or unexplained infertility , The absence of systemic disease, ovarian and no history of failed IVF) and randomly were divided into two groups. The first group (n=70) received oral contraceptive, GnRH, rFSH and HMG. The second group (n=70) , received oral contraceptive, GnRH, rFSH and rLH. Follicular growth was assessed by ultrasonography in every other day. Ovum Pick-Up (OPU) and then about two to three days after oocyte retrieval, embryo transfer (ET) were performed. Fecundity, and the embryos were assessed by embryologists. We assessed the outcomes such as chemical and clinical pregnancy, live birth rate and abortion rate in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092720351N3
Registration date:2016-10-31, 1395/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Ensieh Shahrogh Tehraninejad
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
etehraninejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research , Tehran Medical University.
Expected recruitment start date
2014-10-22, 1393/07/30
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the clinical outcome of ovarian stimulation with hMG + rFSH versus rFSH + rLH in infertile patients undergoing IVF / ICSI .
Public title
Comparison of the Clinical pregnancy outcomes of ovarian stimulation with hMG + rFSH or rFSH + rLH methods in infertile patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 20-35 years;Tubal or unexplained infertility, regular menstruation cycle between 21 and 35 days; Normal function of uterus according to hysterosalpingography; hysteroscopy or transvaginal ultrasonography; Normal ovaries according to transvaginal ultrasonography during past 6 months prior to study and compatible with normal adnexa and normal ovarian anatomy; Serum FSH level less than 8 IU/l.
Exclusion Criteria: Patients with other ovulation disorders such as hypo and hyper-gonadotropic; hypo gonadism; hyper-prolactinemia; thyroid disorders; ovarian or adrenal neoplasms; Cushing syndrome; previous history of systemic diseases such as endocrine and metabolic disorders and a previous history of inappropriate ovarian response to stimulation with gonadotropins (poor responders), prior history of more than 3 unsuccessful IVF; any malformation of sexual organs were excluded
Age
From 20 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Medical School, Ghods Street.
City
Tehran
Postal code
14194
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
911290028
Health conditions studied
1
Description of health condition studied
Female infertility associated with anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
two weeks after embryo transfers
Method of measurement
Blood test
2
Description
Clinical Pregnancy
Timepoint
three weeks after seeing sac fetus
Method of measurement
transvaginal sonography
3
Description
Live birth
Timepoint
after delivery
Method of measurement
Live birth
4
Description
Abortion
Timepoint
two weeks after embryo transfers
Method of measurement
transvaginal sonography
Secondary outcomes
1
Description
Number of oocyte
Timepoint
six day after treatment
Method of measurement
Transvaginal sonography
2
Description
Number of embryo
Timepoint
one day after oocyte pick up
Method of measurement
See under a microscope by a specialist in embryology
Intervention groups
1
Description
TheFirst Interven group (n=70) , received oral contraceptive, GnRH, rFSH and rLH ,150-300 unit subcutaneously.
Category
Treatment - Drugs
2
Description
The second Intervention group (n=70) received oral contraceptive, GnRH, rFSH 150-300 Unit subcutaneosly and 75 Unit of HMG