Protocol summary
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Study aim
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To compare the treatment cycle outcome of two ovarian stimulation protocols, MPA co-treatment with gonadotropin protocol and GnRH antagonist protocol in patients with polycystic ovarian syndrome
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Design
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A randomized, open lable controlled clinical trial with a parallel group design of 232 patients
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Settings and conduct
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232 eligible infertile patients with PCOS who will refer to infertility clinic of Royan Institue for infertility treatment and are underwent IVF/ICSI will be entered the study with ethic consideration.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria including: PCOS as diagnosed by Rotterdam criteria, BMI less than 30kg/m2 and age between 18 to 39 years.The women with significant systemic disease such as renal failure, endometriosis grade 3 or higher, severe male factor infertility, received hormonal treatments in the previous 3 months and those who have contraindications to ovarian stimulation won’t be included in the study.
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Intervention groups
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Patients in the study group will receive rFSH (with or without HMG) at a dose of 150 to 225 IU/day and MPA 10 mg/day from day 3 of menstruation. In the control group, rFSH (with or without HMG) at a dose of 150 to 225 IU/day will be given at a dose of 150 to 225 IU/day from day 3 of menstruation and GnRH antagonist (cetrotide 0.25mg) is administered.
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Main outcome variables
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Fertiliozation rate; number of retrieved oocytes; quality of MII oocyte; OHSS occurrence; premature LH surge; clinical pregnancy rate
General information
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Reason for update
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The declaration of completion for the clinical trial
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Acronym
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IVF/ICSI, BMI, PCOS,TESE-PESA
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IRCT registration information
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IRCT registration number:
IRCT20080831001141N33
Registration date:
2021-01-01, 1399/10/12
Registration timing:
registered_while_recruiting
Last update:
2026-06-10, 1405/03/20
Update count:
1
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Registration date
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2021-01-01, 1399/10/12
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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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Expected recruitment start date
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2019-05-28, 1398/03/07
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Expected recruitment end date
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2025-06-11, 1404/03/21
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Actual recruitment start date
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2020-01-01, 1398/10/11
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Actual recruitment end date
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2022-11-29, 1401/09/08
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Trial completion date
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2025-12-21, 1404/09/30
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Scientific title
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Comparison of Ovarian Stimulation Cycle Outcome in Medroxy Progesterone Acetate and Gonadotropin Protocol with Antagonist and Gonadotropin Protocol in Polycystic Ovarian Syndrome Patients Undergoing In-Vitro fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI)
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Public title
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Comparison of Two Ovarian Stimulation Protocols in Polycystic Ovarian Syndrome (PCOS) Patients Undergoing IVF/ICSI
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The major criteria for diagnosis of PCOS are oligo and/or anovulation, clinical or biochemical signs of hyperandrogenism and polycystic ovaries; these criteria are in accordance with the revised 2003 Rotterdam criteria for PCOS
Age between 18 to 39 years
Body mass Index (BMI) less than 30 kg/m2
Exclusion criteria:
Clinically significant systemic disease such as renal failure
Endometriosis grade 3 or higher
Received hormonal treatments in the previous 3 months
Any contraindications to ovarian stimulation
Sever male factor (TESE-PESA)
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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:
232
Actual sample size reached:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization method is designed by epidemiologist using randomization website and the number of blocks considered is 4. As soon as the patient is entered into the study, the treatment code is determined from the randomly generated sequence and a unique identification code is assigned to the patient. Random codes are stored in the main project management unit of the study and are inqueried through the clinical caregiver and the relevant intervention will be applied to the new patient. For this purpose, after determining the patient eligibility, the clinical caregiver, inquiries from the project management unit and announces the patient information and receives the patient's assigned identification and treatment code. Therefore, the clinical caregiver will not be aware of the allocative treatment until the patient is admitted.
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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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2019-05-28, 1398/03/07
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Ethics committee reference number
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IR.ACECR.ROYAN.REC.1398.057
Health conditions studied
1
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Description of health condition studied
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Polycystic ovarian syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Fertilization rate
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Timepoint
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16-18 hours after sperm insemination or injection
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Method of measurement
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The ratio between the number of zygotes with two pronucleus and the injected oocytes
Secondary outcomes
1
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Description
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Quality of retrieved oocytes including GV, MI, MII
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Timepoint
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Immediately after oocyte puncture
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Method of measurement
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GV: Germinal vesicle present in the ooplasm; MI: No visible GV in the ooplasm and no first polar body in the perivitelline space; MII: Small perivitelline space containing a single unfragmented first polar body
2
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Description
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Number of MII oocytes
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Timepoint
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Immediately after oocyte puncture
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Method of measurement
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Observation of oocytes that were mature at the time of oocyte collection
3
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Description
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OHSS occurrence
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Timepoint
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From puncture to subsequent mensturation
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Method of measurement
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Classification system according to the Navot scheme, including mild, moderate and severe forms
4
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Description
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Premature LH surge
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Timepoint
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During ovarian stimulation until the day of triggering
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Method of measurement
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Serum LH level of equally or more than 10 mIU or an increase of more than 2.5 times above the basal level
5
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Description
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Clinical pregnancy
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Timepoint
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4-6 weeks after embryo transfer
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Method of measurement
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The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG
6
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Description
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Cumulative live birth rate
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Timepoint
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Delivery of a live fetus after the 24th week of pregnancy with vital activity
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Method of measurement
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The sum of live birth events resulting from embryo transfers following an ovarian stimulation cycle performed in the study, divided by the number of patients in each group.
7
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Description
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The rates of obstetrics complications including gestational diabetes, preeclampsia and preterm birth
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Timepoint
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20 to 42 weeks of pregnancy
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Method of measurement
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Diagnosed cases of gestational diabetes, preeclampsia, and preterm labor will be followed up and recorded by a gynecologist during pregnancy in all patients.
8
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Description
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Neonatal outcomes
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Timepoint
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At birth and a week later
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Method of measurement
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The neonatologist will evaluate the gestational age, baby's sex, birth weight, presence of congenital abnormalities, diagnosis of respiratory distress syndrome, and diagnosis of jaundice within the first week of birth. The details regarding the newborn will be documented and monitored through phone follow-ups.
Intervention groups
1
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Description
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Intervention group: Patients will receive rFSH (with or without HMG) at a dose of 150 to 225 IU/day and MPA 10 mg/day from day 3 of menstruation.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients will receive rFSH (with or without HMG) at a dose of 150 to 225 IU/day from day 3 of menstruation and GnRH antagonist (cetrotide 0.25mg) is administered.
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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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Royan Institute
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable