Comparison of ovarian response to ovulation induction after laparoscopic cystectomy or medical management among infertile women with endometrioma undergoing assisted reproductive technology
The purpose of this study is to compare the ovarian response to ovulation induction after laparoscopic cystectomy or medical management among infertile women suffering from endometrioma going through assisted reproductive technology. Our main objective is to define the exact number of oocytes retrieved after these two processes. The sample includes all infertile women aged 40 years or less, with asymptomatic endometrioma undergoing assisted reproductive technology. Diagnosis of endometrioma is based on the evidence found through trans vaginal ultrasound indicating round shaped homogeneous hypoechoe tissue. Infertile couples with maternal cause who undergo TESE (Testicular Sperm Extraction) or PESA (Percutaneous Epididimal Sperm Aspiration) are excluded from the current study. The sample includes 80 patients divided in two groups. First group involves patients with asymptomatic endometrioma receiving IM Dipherelin prior to ovulation induction and the second group are the patients undergoing ovulation induction after laparoscopic ovarian cystectomy followed by IM Dipherelin injection. All patients in both groups receive a single IM dose of Dipherelin monthly for 3 consecutive months before the start of ovulation induction by Gonadotropins. After observing at least two 18 mm follicles in trans vaginal ultrasound, 10 000 units, hCG (10000 units, 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106116689N2
Registration date:2012-11-05, 1391/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-05, 1391/08/15
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
2012-01-04, 1390/10/14
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ovarian response to ovulation induction after laparoscopic cystectomy or medical management among infertile women with endometrioma undergoing assisted reproductive technology
Public title
Treatment of endometrioma in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile women with endometrioma requiring assisted reproductive technology
Exclusion criteria: Age over 40 years; Endometrioma smaller than 2 cm or larger than 6 cm; Male infertility TESE (Testicular Sperm Extraction) or PESA (Percutaneous Epididimal Sperm Aspiration)
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All volenteers with inclusion criteria are asked to participate in the current study if agreed, a informed consent form is signed. she is randomly assigned to one of two groups based in Bertoli distribution. If she has an objection, we will switch her to another group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Sciences
Street address
Ethic Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran
City
Tehran
Postal code
Approval date
2012-01-02, 1390/10/12
Ethics committee reference number
90-02-30-14261-40996
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
ناباروري زنانه
2
Description of health condition studied
Endometriomas
ICD-10 code
N80.1
ICD-10 code description
اندومتريوزيزدرتخمدان
Primary outcomes
1
Description
The number of retrieved oocytes
Timepoint
84 days after the first Dipherelin injection
Method of measurement
Invert Microscope, Diaphot 300, Nikon, Japan
Secondary outcomes
1
Description
The number of dominant follicles
Timepoint
82 days after the first Dipherelin injection
Method of measurement
nGS= number of observed gestatinal sac in trans vaginal sonography, nET= number of embryonal transfer, clinical pregnancy rate(%)= nGS/ nET x100
2
Description
fertilization rate
Timepoint
87 days after the first Dipherelin injection
Method of measurement
nE= number of total embryos, nI= number of injected oocytes, fertilization rate(%)= nE/ nI x 100
3
Description
The number and quality of embryos
Timepoint
87 days after the first Dipherelin injection
Method of measurement
Invert Microscope, Diaphot 300, Nikon, Japan
4
Description
chemical pregnancy
Timepoint
101 days after the first Dipherelin injection
Method of measurement
βhCG test
5
Description
clinical pregnancy rate
Timepoint
115 days after the first Dipherelin injection
Method of measurement
nGS= number of observed gestatinal sac in trans vaginal sonography, nET= number of embryonal transfer, clinical pregnancy rate(%)= nGS/ nET x100
Intervention groups
1
Description
First group receives 3 consecutive single IM doses of Dipherelin 3.75mg (Beaufouipfen, France) in 3 consecutive months.Ten days after the third IM dose of Dipherelin ovarian stimulation is conducted by using Gonal F (Serono, Switzerland, 300-450IU daily), for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-450IU daily) until the observation of 18mm follicles in trans vaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 4 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU, 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, 3 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 oocytes retrieved, dominant follicles, embryos; quality of embryos;the rate of fertilization, laboratory and clinical pregnancy are compared between two groups.
Category
Treatment - Drugs
2
Description
Second group receives 3 consecutive single IM doses of Dipherelin 3.75mg (Beaufouipfen, France) in 3 consecutive months after laparoscopic ovarian cystectomy. Ten days after the third IM dose of Dipherelin ovarian stimulation is conducted by using Gonal F (Serono, Switzerland, 300-450IU daily), for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-450IU daily) until the observation of 18mm follicles in trans vaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20, Siemens Medical Solutions, California, USA) is performed every 4 days. After observing at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU, 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 is carried out. Detection of pregnancy is through serum BhCG analysis, 3 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 oocytes retrieved, dominant follicles, embryos; quality of embryos;the rate of fertilization, laboratory and clinical pregnancy are compared between two groups.
Category
Treatment - Surgery
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 Leili Safdarian
Position
Associated 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
safdarian@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)