Protocol summary
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Study aim
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Assessment of infertility treatment success by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures referred to infertility clinic of Arash women hospital: a clinical trial
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Design
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a randomized clinical trial with a parallel-group design of 34 patients. We will use the block randomization method by using: www.sealedenvelope.com
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Settings and conduct
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This clinical trial is conducted to evaluate 34 infertile eligible patients with PCOS who refer to Arash Women's Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women with poly cystic ovary syndrome who have two of the three diagnostic criteria Rotterdam at least, age between 18- 35 year- old, body mass index less than 39, infertility for over a year, normal semen analysis in their spouse, previous failed IVF procedures at least for 2 times.
ٍExclusion criteria: Aged more than 39 year- old
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Intervention groups
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]n the intervention group, laparoscopic ovarian catheter surgery is performed for patients using 40-watt bipolar current at 4-6 points of the ovary and a month later, IVF / ET cycle treatment is performed. In the control group, patients enter the IVF / ET cycle without laparoscopic ovarian catheterization.
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Main outcome variables
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The oocyte and embryo quality, pregnancy loss, clinical pregnancy rate, pregnancy complications (gestational diabetes, preterm delivery, hypertension, and preeclampsia ) OHSS
General information
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Reason for update
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The trial completion was 9 months after the actual recruitment end date, which was corrected in the system.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090526001952N14
Registration date:
2021-02-17, 1399/11/29
Registration timing:
retrospective
Last update:
2022-12-13, 1401/09/22
Update count:
2
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Registration date
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2021-02-17, 1399/11/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tehran University of Medical Sciences
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Expected recruitment start date
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2016-12-04, 1395/09/14
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Expected recruitment end date
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2017-03-31, 1396/01/11
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Actual recruitment start date
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2015-08-22, 1394/05/31
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Actual recruitment end date
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2017-03-31, 1396/01/11
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Trial completion date
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2018-01-01, 1396/10/11
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Scientific title
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Assessment of infertility treatment success by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures referred to infertility clinic of Arash women hospital: a clinical trial
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Public title
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Assessment of pregnancy rate by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with poly cystic ovary syndrome who have two of the three diagnostic criteria Rotterdam at least
Age between 18- 35 year- old
Body mass index less than 30
Normal semen analysis in their spouse
Previous failed IVF procedures at least for 2 times
No laparoscopic contraindications
Exclusion criteria:
Aged more than 39 year
Previous ovarian surgery
Co-existing endocrine diseases including diabetes mellitus, estrogen-dependent tumors, thyroid disease, Cushing’s syndrome, or congenital adrenal hyperplasia
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Age
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From 18 years old to 39 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
34
Actual sample size reached:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization method is on the basis of a block randomization list which is designed by an epidemiologist colleague using the Stata software (LLC StataCorp, USA) version 13 and a block size of 6. The random allocation process is concealed by providing 34 consecutive treatment cards that is placed in sealed envelopes. A random 10-digit code is written without sequence and frame on each envelope. This relevant code is patient’s identification number, and just the project methodologist has known that this code is related to which treatment group. When the doctor announces that a patient is eligible, the methodologist has provided the doctor with an envelope design and the desired treatment is selected based on the type mentioned in the envelope. The outcome’s evaluator also is considered of a third party person who is unaware of the type of treatment performed. The data analysis is performed by a statistician who is unaware of all the study‘s processes.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-08-09, 1394/05/18
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Ethics committee reference number
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IR.TUMS.REC.1394.542
Health conditions studied
1
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Description of health condition studied
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infertility
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ICD-10 code
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N97.0
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ICD-10 code description
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Female infertility associated with anovulation
Primary outcomes
1
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Description
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Chemical pregnancy rate
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Timepoint
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Beta-hCG test 14 days after embryo transfer
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Method of measurement
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Laboratory kits for Beta-hCG assay
2
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Description
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Clinical pregnancy rate
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Timepoint
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6 to 7 weeks after embryo transfer
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Method of measurement
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Observing the gestational sac along with fetal heart activity in vaginal ultrasound
Secondary outcomes
1
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Description
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oocyte quality
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Timepoint
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Ovum pick-up day
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Method of measurement
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The number of Metaphase II oocytes obtained on the day of ovulation, which is reported by the embryologist
2
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Description
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Abortion rate
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Timepoint
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before 20th week of pregnancy
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Method of measurement
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sonography
3
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Description
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Embryo quality
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Timepoint
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before transfer
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Method of measurement
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It is determined by the embryologist based on the number of blastomeres and the percentage of fragmentation, multinucleation and symmetry on the third day after oocyte retrieval.
4
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Description
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Live birth rate
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Timepoint
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The delivery of a fetus who shows evidence of life after that is entirely outside of the mother
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Method of measurement
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Through hospital reports and telephone follow-up of patients
5
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Description
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The pregnancy complications
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Timepoint
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during 9 months of pregnancy
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Method of measurement
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Complications such as premature delivery or premature rupture of the amniotic sac before 37 weeks of pregnancy and diagnosis of blood pressure above 140/90 (hypertension) along with edema and excretion of protein in the urine (Preeclampsia) as well as diagnosis of gestational diabetes (fasting plasma glucose equal to or greater than 92 mg/dL) with glucose 1 hour after consuming 75 grams of glucose equal to or more than 180 mg/dL) is recorded through checking the hospital report and telephone follow-up.
6
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Description
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Ovarian hyperstimulation syndrome rate
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Timepoint
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3 and 10 days after ovarian puncture
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Method of measurement
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Examination of symptoms, signs of ovarian hyperstimulation (mild to moderate pain in the abdomen, bloating or increased waist size, nausea and vomiting, diarrhea, tenderness in the ovaries) and vaginal ultrasound
Intervention groups
1
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Description
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Intervention group: Laparoscopic ovarian drilling is performed using 40-watt bipolar current at 4-6 points of the ovaries for patients and a month later undergo in vitro fertilization (IVF) cycle with ovarian stimulation using an antagonist protocol.
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Category
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Treatment - Surgery
2
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Description
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Control group: In this group, patients without laparoscopic ovarian drilling are treated only for in-vitro fertilization (IVF) cycle with ovarian stimulation using antagonist protocol.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is not a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available