The Evaluation of The Effects of Mild Ovarian Stimulation on IVF(in vitro fertilization ) Results In Comparison With Conventional Method ,The Infertility Center Hospital Patients,2012-2013
Objective: The aim of this clinical trial was to compare the therapeutic effects of two ovarian stimulation methods (i.e. mild and conventional) on IVF outcomes.
Study design: Inclusion criteria : women between 18 and 35 years of age with regular menses who were undergoing their first IVF. Exclusion criteria :established systemic disease and repeated abortions. The target population consisted of 204 female patients presenting to the infertility center. Patients were entered into the study after thorough evaluation and informed consent. Patients were randomly divided into two groups using a computer.
Method: Patients were randomly divided into two groups of A and B. Both groups underwent treatment with gonadotropins. However, patients in the former group were given GNRH agonists, while GNRH antagonists and clomiphene citrate were administered to their counter parts in group B.
Interventions: In group A, a conventional ovarian stimulation method was applied in that patients were given Superfact 500 micrograms SQ from day 21 of their menstrual cycle followed by a reduction in dose to 250 micrograms per day on the 3rd day of the cycle together with recombinant FSH at 225-150 IU for stimulation. As for group B, mild ovarian stimulation using 100mg of clomiphene citrate was initiated from days 3 to 7 of the menstrual cycle. Gonadotropin-induced stimulation was begun on day 5 at a dose of 75 IU and the course was followed by a control ultrasound exam on day eight. In both groups, follicles were obtained for IVF or ICSI using transvaginal ultrasonic guided puncture 34-36 hours after the injection of HCG.
Outcomes: The primary outcomes were the determination of the number of chemical and clinical pregnancies, while secondary outcomes included evaluating the number of fetuses, the number of frozen fetuses, and possible complications (e.g. multiparities;implantation rates; and the OHSS syndrome).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030516858N1
Registration date:2014-04-01, 1393/01/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-01, 1393/01/12
Registrant information
Name
Sepideh Peyvandi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4443 0501
Email address
drspeyvandi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of The Effects of Mild Ovarian Stimulation on IVF(in vitro fertilization ) Results In Comparison With Conventional Method ,The Infertility Center Hospital Patients,2012-2013
Public title
Compare Two Different Methods of Ovarian Stimulation On Outcome of In Vitro Fertilization (IVF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female patient age 18–35 years; presence of a regular
; proven ovulatory menstruation cycle with a length of 26–35 days, more that 5 million sperm in SA(semen analysis);body mass index (BMI)
of 18–30 kg/m ; first IVF attempt .
Exclusion criteria:established systemic disease ;ovary and Uterus abnormalities;repeated abortions.
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:
204
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
Mazandaran University of Medical Sciences
Street address
Payambar Aazam Department, 18th kilometer of Sea Roud, SARI , MAZANDARAN , IRAN
City
Sari
Postal code
Approval date
2012-11-07, 1391/08/17
Ethics committee reference number
91-179
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female Infertility
Primary outcomes
1
Description
Increase Endometrial Thickness
Timepoint
2 Days After HCG Injection
Method of measurement
Sonography
2
Description
Increase Implantation
Timepoint
3 week
Method of measurement
Lab Test
3
Description
Increase Chemical Pregnancy
Timepoint
12 Day
Method of measurement
ß-hCG
4
Description
Increase Clinical Pregnancy
Timepoint
3 week
Method of measurement
Sonography
5
Description
Decrease Treatment Cost
Timepoint
Delivery Time
Method of measurement
Counting-RIALs
Secondary outcomes
1
Description
Decrease OHSS Syndrom
Timepoint
Delivery Time
Method of measurement
Counting
2
Description
Decrease of Multiple Pregnancy
Timepoint
Delivery Time
Method of measurement
Counting
3
Description
Increase Of Follicular Number
Timepoint
8 Day
Method of measurement
Counting
4
Description
Increase Of Ovoocyt Number
Timepoint
10 Days
Method of measurement
Counting
5
Description
Increase Of Embryo Freez
Timepoint
3week
Method of measurement
Counting
Intervention groups
1
Description
Control Group(group active control or standard ) :The Cases in This Group Will Be Treated with Conventional Ovarian Stimulation .They Desensitized with OCP ,Sarting on 3th Cycle Day.in Menstrual Cycle 21th Day, They Were Injected 0.5 cc Superfact (GNRH-a),(S.C) and in 3th Day of Menstrual
Bleeding The Dosage Was Changed Into The 0.25 cc (S.C) In The Patients.
Ovarian Stimulation Was Started With 150–225 IU Recombinant FSH (r_FSH) S.C.
Category
Treatment - Drugs
2
Description
Patients in Group With New Treatment(mild Ovary Stimulation) Were Stimulated Clomiphene Citrate 100 mg From Cycle Day Three Through Seven and Continuous Gonadotropin Stimulation With Of r_FSH 75 IU Daily From Cycle Day 5.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic Of Emam Khomaini Hospital
Full name of responsible person
MRs soltani-Mrs rasouli
Street address
Emam Khomeini Hospital, Amir Mazandarani Street , SARI ,MAZANDARAN, IRAN
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mr gholami
Street address
sari 18th km sea roud.payambar aazam department
City
sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Sepideh Peyvandi
Position
cheif -Associated professor of Obstetric and Gynecology-fellowship of infertility
Other areas of specialty/work
Street address
Emam Khomaini Hospital, Amir Mazandarani Street , SARI,MAZANDARAN ,IRAN