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Protocol summary
Inclusion criteria: infertile PCOS patients which are the candidate for ART
Exclusion criteria: women older than 40 years; history of endocrine disorder; intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions); severe endometriosis; and azoospermia of partner.
Inclusion criteria: infertile PCOS patients which are the candidate for ART
Exclusion criteria: systemic disease; history of endocrine disorder; intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions); severe endometriosis; and azoospermia of partner.
Inclusion criteria: infertile PCOS patients which are the candidate for ART Exclusion criteria: women older than 40 yearssystemic disease; history of endocrine disorder; intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions); severe endometriosis; and azoospermia of partner.
معیارهای ورود:بیماران PCOS نابارور که کاندید ART هستند.
معیارهای خروج: زنان مسن تراز40سال؛سابقه بیماریهای اندوکرین؛ضایعات داخل رحمی(میوم و پولیپ و چسبندگی) ؛سابقه اندومتریوز شدید ؛ازواسپرمی همسر می باشد.
معیارهای ورود:بیماران PCOS نابارور که کاندید ART هستند.
معیارهای خروج: بیماریهای سیستمیک؛سابقه بیماریهای اندوکرین؛ضایعات داخل رحمی(میوم و پولیپ و چسبندگی) ؛سابقه اندومتریوز شدید ؛ازواسپرمی همسر می باشد.
معیارهای ورود:بیماران PCOS نابارور که کاندید ART هستند. معیارهای خروج: زنان مسن تراز40سالبیماریهای سیستمیک؛سابقه بیماریهای اندوکرین؛ضایعات داخل رحمی(میوم و پولیپ و چسبندگی) ؛سابقه اندومتریوز شدید ؛ازواسپرمی همسر می باشد.
progesterone prime group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months latter.
Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months later.
progesterone prime group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months latter.
Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously.vaginal sonography will be done for all women since 6th day of cycle. When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months later.
progesterone prime group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months latter. Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) SubcutaneouslySubcutaneously.vaginal sonography will be done for all women since 6th day of cycle. When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months later.
گروه شروع با پروژسترون:بیماران از روز دوم سیکل روزانه روزانه 150 واحد سینال اف(سیناژن-ایران) زیر جلدی و 20 دیدروژسترون (دوفاستون) خوراکی دریافت میکنند وقتی فولیکول پیشرو به 17 میلیمتر رسید تحریک نهایی تخمکگذاری انجام میشود و 36 ساعت بعد پونکسیون تخمدانها انجام می شود. کلیه جنینها در مرحله کلیواژ فریز میشوند و انتقال جنین های فریز شده 2 ماه دیگر انجام میشود.
گروه آنتاکونیست: بیماران از روز دوم سیکل روزانه روزانه 150 واحد سینال اف(سیناژن-ایران) زیر جلدی دریافت میکنند.وقتی فولیکول پیشرو به 13-12 میلیمتر رسید ستروتاید (مرک-سرنو آلمان) روزانه 25. روزانه زیر جلدی شروع میشود وقتی فولیکول پیشرو به 17 میلیمتر رسید تحریک نهایی تخمکگذاری انجام میشود و 36 ساعت بعد پونکسیون تخمدانها انجام می شود. 48 کلیه جنینها در مرحله کلیواژ فریز میشوند و انتقال جنین های فریز شده 2 ماه دیگر انجام میشود.
گروه شروع با پروژسترون:بیماران از روز دوم سیکل روزانه روزانه 150 واحد سینال اف(سیناژن-ایران) زیر جلدی و 20 دیدروژسترون (دوفاستون) خوراکی دریافت میکنند وقتی فولیکول پیشرو به 17 میلیمتر رسید تحریک نهایی تخمکگذاری انجام میشود و 36 ساعت بعد پونکسیون تخمدانها انجام می شود. کلیه جنینها در مرحله کلیواژ فریز میشوند و انتقال جنین های فریز شده 2 ماه دیگر انجام میشود.
گروه آنتاکونیست: بیماران از روز دوم سیکل روزانه روزانه 150 واحد سینال اف(سیناژن-ایران) زیر جلدی دریافت میکنند.از روز ششم سیکل همه ی بیماران تحت سونوگرافی واژینال قرار میگیرند. وقتی فولیکول پیشرو به 13-12 میلیمتر رسید ستروتاید (مرک-سرنو آلمان) روزانه 25. روزانه زیر جلدی شروع میشود وقتی فولیکول پیشرو به 17 میلیمتر رسید تحریک نهایی تخمکگذاری انجام میشود و 36 ساعت بعد پونکسیون تخمدانها انجام می شود. 48 کلیه جنینها در مرحله کلیواژ فریز میشوند و انتقال جنین های فریز شده 2 ماه دیگر انجام میشود.
گروه شروع با پروژسترون:بیماران از روز دوم سیکل روزانه روزانه 150 واحد سینال اف(سیناژن-ایران) زیر جلدی و 20 دیدروژسترون (دوفاستون) خوراکی دریافت میکنند وقتی فولیکول پیشرو به 17 میلیمتر رسید تحریک نهایی تخمکگذاری انجام میشود و 36 ساعت بعد پونکسیون تخمدانها انجام می شود. کلیه جنینها در مرحله کلیواژ فریز میشوند و انتقال جنین های فریز شده 2 ماه دیگر انجام میشود. گروه آنتاکونیست: بیماران از روز دوم سیکل روزانه روزانه 150 واحد سینال اف(سیناژن-ایران) زیر جلدی دریافت میکنند.وقتیمیکنند.از روز ششم سیکل همه ی بیماران تحت سونوگرافی واژینال قرار میگیرند. وقتی فولیکول پیشرو به 13-12 میلیمتر رسید ستروتاید (مرک-سرنو آلمان) روزانه 25. روزانه زیر جلدی شروع میشود وقتی فولیکول پیشرو به 17 میلیمتر رسید تحریک نهایی تخمکگذاری انجام میشود و 36 ساعت بعد پونکسیون تخمدانها انجام می شود. 48 کلیه جنینها در مرحله کلیواژ فریز میشوند و انتقال جنین های فریز شده 2 ماه دیگر انجام میشود.
Primary outcomes
#1
Chemical pregnancy
chemical pregnancy
Chemicalchemical pregnancy
حاملگي شيميايي
حاملگی شیمیایی
حاملگي شيمياييحاملگی شیمیایی
15 days after embryo transfer
Two weeks after embryo transfer
15 daysTwo weeks after embryo transfer
15 روز بعد از انتقال جنین
دو هفته بعد از انتقال جنین
15 روزدو هفته بعد از انتقال جنین
Blood laboratory kit
Serum BhCG
Blood laboratory kitSerum BhCG
کیت آزمایشگاهی خون
بتا اچ سی جی سرم
کیت آزمایشگاهی خونبتا اچ سی جی سرم
#2
3 weeks after positive beta-h Cg
Two weeks after positive BhCG
3Two weeks after positive beta-h CgBhCG
3 هفته بعد از مثبت شدن بتا اچ سی جی
دو هفته بعد از مثبت شدن بتا اچ سی جی
3دو هفته بعد از مثبت شدن بتا اچ سی جی
Observation of fetal heart activity by transvaginal ultrasonography
sonography
Observation of fetal heart activity by transvaginal ultrasonographysonography
مشاهده قلب جنین با سونوگرافی واژینال
سونوگرافی
مشاهده قلب جنین با سونوگرافی واژینال
Recruitment centers
#1
Name of recruitment center - English: Yazd Reaserch and clinical for infertility
Name of recruitment center - Persian: مرکز تحقیقات ناباروری یزد
Full name of responsible person - English: Abbas Aflatoonian
Full name of responsible person - Persian: عباس افلاطونیان
Street address - English: Bouali
Street address - Persian: بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax:
Email: abbas/aflatoonian@ssu.ac.ir
Web page address:
Name of recruitment center - English: Yazd Research and Clinical Center for Infertility
Name of recruitment center - Persian: مرکزتحقیقاتی و درمانی ناباروری یزد
Full name of responsible person - English: Maryam Eftekhar
Full name of responsible person - Persian: مريم افتخار
Street address - English: Boali Ave., Safayeh
Street address - Persian: صفاییه خیابان بوعلی
City - English: Yazd
City - Persian: تهران
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax:
Email: eftekharmaryam@yahoo.com
Web page address:
Name of recruitment center - English: Yazd ReaserchResearch and clinicalClinical Center for infertilityInfertility Name of recruitment center - Persian: مرکز تحقیقاتمرکزتحقیقاتی و درمانی ناباروری یزد Full name of responsible person - English: Abbas AflatoonianMaryam Eftekhar Full name of responsible person - Persian: عباس افلاطونیانمريم افتخار Street address - English: BoualiBoali Ave., Safayeh Street address - Persian: صفاییه خیابان بوعلی City - English: Yazd City - Persian: یزدتهران Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Fax: Email: abbas/aflatoonianeftekharmaryam@ssu.ac.iryahoo.com Web page address:
Protocol summary
Study aim
The purpose of this study is to compare and compare pregnancy rates using progesterone prime protocol and antagonist protocol in patients with the polycystic ovarian syndrome who are the candidate for ART.
Design
The clinical trial with the randomized control group
Settings and conduct
Randomized clinical trial without blindness,
Participants/Inclusion and exclusion criteria
Inclusion criteria: infertile PCOS patients which are the candidate for ART
Exclusion criteria: systemic disease; history of endocrine disorder; intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions); severe endometriosis; and azoospermia of partner.
Intervention groups
progesterone prime group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months latter.
Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously.vaginal sonography will be done for all women since 6th day of cycle. When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done and 36 hours later. all embryo will be freez in cleavage stage and frozen embryo transfer will be done 2 months later.
Main outcome variables
Clinical pregnancy rat
General information
Reason for update
Update corrections and study results
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006420N18
Registration date:2018-08-20, 1397/05/29
Registration timing:retrospective
Last update:2021-06-28, 1400/04/07
Update count:2
Registration date
2018-08-20, 1397/05/29
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2018-06-24, 1397/04/03
Trial completion date
2019-01-07, 1397/10/17
Scientific title
progestin primed ovarian stimulation protocol in patients with the polycystic ovarian syndrome in assisted reproductive technology cycles
Public title
progestin primed ovarian stimulation protocol in the polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
infertile PCOS patients which are candidate for ART
Exclusion criteria:
women older than 40 years old
History of endocrine disorder
Severe endometriosis
Azoospermia
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by sealed envelops.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Infertility Research Center, Shahid Sadoughi University of Medical Sciences, Yaz
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.SSU.RSI.REC.1397.003
Health conditions studied
1
Description of health condition studied
Female infertility, unspecified
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Serum BhCG
2
Description
Clinical pregnancy
Timepoint
Two weeks after positive BhCG
Method of measurement
sonography
Secondary outcomes
1
Description
Miscarriage rate
Timepoint
Loss of pregnancy before 20 gestational week
Method of measurement
Absence of fetal heart activity in ultra sound sonography
Intervention groups
1
Description
Intervention group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm,final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.48 latter all embryo will be freeze in cleavage stage and frozen embryo transfer will be done 2 months latter after preparation of endometer by estrogen and progesterone.
Category
Treatment - Drugs
2
Description
Control group: Antagonist group: since second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyle - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.48 latter all embryo will be freeze in cleavage stage and frozen embryo transfer will be done 2 months later after preparation of endometer by estrogen and progestrone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Street address
Boali Ave., Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Robab Davar
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
Davar@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of patients
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The study protocol, the statistical analysis map, the clinical study report will be available after the publishing of the article
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
use in the retrospective study
From where data/document is obtainable
Yazd research and clinical center for infertility
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.
سایر توضیحات
فا خالی
Comments
Trial results
Please tick if results have been published
Yes
Summary result posting date
2021-03-17, 1399/12/27
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
empty
Abstract of published paper
AbstractBackground: In vitro fertilization is an important therapy for women with the polycystic ovarian syndrome (PCOS). The use of new ways of improving clinical results is yet required. Objective: This study was aimed to investigate the efficacy of progesterone primed ovarian stimulation (PPOS) and compare with conventional antagonist protocol in PCOS.Materials and Methods:A total of 120 PCOS women who were candidates for assisted reproductive technology treatment were enrolled in this RCT and were placed into two groups, randomly (n = 60/each). The PPOS group received 20 mg/day Dydrogesterone orally since the second day of the cycle and the control group received antagonist protocol. The pregnancy outcomes including the chemical and clinical pregnancy, the miscarriage rate, and the percent of gestational sacs/transferred embryos were compared in two groups.Results:Number of MII oocyte, maturity rate, Number of 2 pronuclei (2PN) and serum estradiol levels on trigger day were statistically lower in PPOS group (p = 0.019, p =0.035, p = 0.032, p = 0.030), respectively. Serum LH level on trigger day in PPOSgroup was higher than antagonist group (p = 0.005). Although there wasn’t severe ovarian hyperstimulation syndrome in any participants, mild and moderate ovarian hyperstimulation syndrome was less in PPOS group (p = 0.001). Also, the chemical and clinical pregnancy rates were higher in the antagonist group, although it was not statistically significant (p = 0.136, p = 0.093 respectively).Conclusion: Our study demonstrates that PPOS does not improve the chemical and clinical pregnancy rate of infertile women with PCOS.