Comparison of ovarian response to ovulation induction after "Minidose long agonist" and "GnRH-agonist/GnRH-antagonist" protocols among poor responder infertile women who undergoing assisted reproductive technology
The purpose of this study is to compare the ovarian response to ovulation induction after "Minidose long agonist" and "GnRH-agonist/GnRH-antagonist" protocols among poor responder infertile women. The sample includes all Infertile women with at least two episodes of poor responses following maximal stimulation or at least two of the following three conditions: 1- Advanced maternal age (40 years old or greater) 2- A history of IVF failure (retrieved 3 oocytes or lesser) 3- An abnormal ovarian reserve test (Antral Follicle Count 5 or lesser in early follicular phase or Antimulerian hormone less than 1mIU/ml). Infertile couples who undergo TESE (Testicular Sperm Extraction) or PESA (Percutaneous Epididymal Sperm Aspiration); uterine myoma with 4cm size or greater; endometriosis (stage 3 or 4); or maternal age greater than 43 years old are excluded from the current study. The sample includes 100 patients divided in two groups randomly. First group involves patients receiving minidose long agonist GnRH prior to ovulation induction and the second group is the patients undergoing ovulation induction with mixed agonist and antagonist GnRH protocol. After observing at least two 18 mm follicles in trans vaginal ultrasound, hCG (10000 units and IM) is injected. The following step is ovarian puncture guided by trans vaginal ultrasound under general anesthesia 36 hours later. Trans cervical embryo transfer is performed 3 days after the puncture. In this study, the following outcomes are compared between two groups: number of retrieved oocytes, dominant follicles, embryos; quality of embryos; the rate of fertilization, chemical and clinical pregnancy, cancellation of ovulation induction cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106026689N1
Registration date:2014-05-16, 1393/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-16, 1393/02/26
Registrant information
Name
Sedigheh Hosseinimousa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 8810
Email address
hoseinimosa@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2013-08-17, 1392/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ovarian response to ovulation induction after "Minidose long agonist" and "GnRH-agonist/GnRH-antagonist" protocols among poor responder infertile women who undergoing assisted reproductive technology
Public title
Choice of Treatments for Ovulation Induction Among Poor Responders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Infertile women with at least two episodes of poor responses following maximal stimulation or at least two of the following three conditions: 1- Advanced maternal age (40 years old or greater) 2- A history of IVF failure ( retrieved 3 oocytes or less) 3- An abnormal ovarian reserve test (Antral Follicle Count 5 or lesser in early follicular phase or Antimulerian hormone less than 1mIU/ml) Exclusion Criteria: 1-Male infertility which needs interventions such as TESE (Testicular Sperm Extraction) or PESA (Percutaneous Epididymal Sperm Aspiration) 2- Endometriosis (stage 3 or 4) 3- Uterine myoma with 4cm size or greater 4- maternal age greater than 43 years old
Age
From 20 years old to 43 years old
Gender
Female
Phase
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All volunteers with inclusion criteria are asked to participate in the current study if agreed; an informed consent form is signed. She is randomly assigned to one of two groups based in Bernoulli distribution. Initially, patients and physicians were blinded to the treatment group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ethics Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran
City
Tehran
Postal code
1417653761
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
90-04-30-15625-52546
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
The number of retrieved oocytes
Timepoint
The day of oocyte retrieval
Method of measurement
Invert Microscope, Diaphot 300, Nikon, Japan
Secondary outcomes
1
Description
Chemical Pregnancy
Timepoint
19 days after oocyte retrieval
Method of measurement
βhCG titration
2
Description
The number of dominant follicles
Timepoint
48 hours prior to oocyte retrieval
Method of measurement
Transvaginal ultrasonography
3
Description
The number and quality of embryos
Timepoint
48 hours after oocyte retrieval
Method of measurement
Invert Microscope, Diaphot 300, Nikon, Japan
4
Description
Clinical pregnancy rate
Timepoint
33 days after oocyte retrieval
Method of measurement
observed gestational sac in transvaginal sonography
5
Description
Fertilization Rate
Timepoint
The day after oocyte retrieval
Method of measurement
(Total number of embryos/ Total number of injected oocytes)* 100
6
Description
Cancellation rate of cycle
Timepoint
Any time
Method of measurement
the number of cycles not resulted in oocyte retrieval
Intervention groups
1
Description
First group, Minidose Agonist, receives GnRH Agonist (Bucerelin, Aventis, Germany) 50 μg subcutaneously from midluteal cycle (21th day). Ovarian stimulation is conducted by using Gonal F (Serono, Switzerland) 375-600IU daily, for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-600IU daily) until the observation of 18mm follicles in transvaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 3 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU and IM) is injected and after 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization technique, performed through intracytoplasmic sperm injection (ICSI), trans cervical embryo transfer will be carried out. Detection of pregnancy is through serum BhCG analysis, 16 days after embryonic transfer and the clinical pregnancy is detected by the aid of trans vaginal ultrasound, two weeks later when the pregnancy sac is detected. Main outcome is the number of oocytes retrieved. The number of dominant follicles, embryos; quality of embryos; the rate of fertilization, chemical and clinical pregnancy are compared between two groups.
Category
Treatment - Drugs
2
Description
Second group receives Decapeptyle 0.1mg (Ferring, Germany) in 3 consecutive days from the first day of menses. In the third day of menses ovarian stimulation is conducted by using Gonal F (Serono, Switzerland) and HMG (Ferring, Germany) 375-600IU daily. When the 14mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix, Ferring, Germany) 0.25mg daily is added. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 3 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU and IM) is injected and after 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization, technique performed through intra cytoplasmic sperm injection (ICSI), trans cervical embryo transfer will be carried out. Detection of pregnancy is through serum BhCG analysis, 16 days after embryonal transfer and the clinical pregnancy is detected by the aid of trans vaginal ultrasound, two weeks later when the pregnancy sac is detected. Main outcome is the number of oocytes retrieved. The number of dominant follicles, embryos; quality of embryos; the rate of fertilization, chemical and clinical pregnancy, cancellation are compared between two groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Unit, Shariati Hospital
Full name of responsible person
Dr Sedighe Hoseinimosa
Street address
Department of Infertility, Shariati Hospital, Tehran University of Medical Sciences, North Karegar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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 Sciences, Shariati Hospital, Department of Infertility
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Other areas of specialty/work
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
hoseinimosa@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Aghahosseini
Position
Professor
Other areas of specialty/work
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
aghahosseini@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Other areas of specialty/work
Street address
Infertility Unit, Shariati Hospital,North Karegar Street, Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
0O982188220050
Email
hoseinimosa@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)