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Trial details
Trial details
Stress managment and in vitro fertilization outcomes
Current status:
Approved
|
Date registered:
04/11/2019
|
Date last updated:
04/11/2019
Trial version(s)
Current: 19/09/2019
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Main Information
Primary registry identifying number
LBCTR2019101289
Protocol number
OBS-2018-002
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
This is a retrospective registration since, honestly,at the beginning of this trial and while preparing the documents requested by the IRB for the ethical apprval, we were never informed that the trial should be registered.
Date of registration in national regulatory agency
Primary sponsor
Azoury IVF clinic and Al-Hadi laboratory and medical center
Primary sponsor: Country of origin
Lebanon
Public title
Stress managment and in vitro fertilization outcomes
Acronym
SMP
Scientific title
The impact of stress managment during in vitro fertilization on embryo development and mental health
Acronym
SMP
Brief summary of the study: English
STUDY QUESTION Does a stress management program during infertility treatment impact the cortisol level in the follicular fluid and subsequently embryo development? WHAT IS KNOWN ALREADY The process of infertility treatment requires at least one month of preparation. During this period, the women undergo ovarian stimulation using gonadotropins followed by trans-vaginal oocyte aspiration under local anesthesia. Several studies showed that stress and anxiety are common psychological conditions during infertility treatment procedures (Cesta, Johansson et al. 2017). The biological responses to stress involve the regulation of the adrenal glands activity (McEwen 2016). The cortisol, a glucocorticoid hormone secreted by the adrenal gland cortex, plays an important role in the local regulation of human ovarian follicles. For instance, it was demonstrated that cortisol may trigger apoptosis of ovarian cells (Yuan, Han et al. 2016), may regulate the secretion of insulin-like growth factors (IGF-2,4,5) in the granulosa cells (Spicer and Chamberlain 1998), and may influence the oocyte lipid metabolism (Simerman, Hill et al. 2015). However, the impact of stress management on oocyte quality, embryo development, and in vitro fertilization (IVF) outcome did not A randomized controlled trial (RCT) will be conducted at Azoury IVF clinic, Mount-Lebanon hospital. It will be performed on couples undergoing IVF with intra-reach a firm consensus. STUDY DESIGN, SIZE, DURATION cytoplasmic sperm injection cycles. These IVF cycles will be conducted by Dr. Joseph Azoury (MD). At the first day of ovarian stimulation using the antagonist protocol (Gonal-f, Cetrotide, and Ovitrelle), in-person interviews will be conducted with infertile couples to answer a questionnaire about their medical history. In parallel, perceived stress level will be evaluated using the Perceived Stress Scale (PSS). Subsequently, the infertile couples will be randomly divided into two groups (n=50 couples each). One of the groups will be subjected to a stress management program (SMP) during infertility treatment. The stress management program will be under the supervision of Dr.Georges Raad (PhD), Miss Judy Tanios (MSc), and Mrs. Simone Kerbaj (MSc). At the day of egg retrieval, psychological stress of the patients, in both groups, will be assessed using the PSS. PARTICIPANTS/MATERIALS, SETTING, METHODS After egg retrieval, the collected follicular fluid will be centrifuged. The supernatant will be used for cortisol measurements and the granulosa cells in the pellet will be cryopreserved for further molecular investigations at Al Hadi medical and laboratory center. Moreover, oocyte quality and embryo morphokinetics will be analysed according to international guidelines through time-lapse microscopy (Embryoscope) using the Embryoviewer software. COMPETING INTEREST(S) No conflict of interest.
Brief summary of the study: Arabic
المسألة هل يؤثر برنامج إدارة الإجهاد أثناء علاج العقم على مستوى الكورتيزول في السائل المسامي ومن ثم تطور الجنين؟ الخلفية العلمية تتطلب عملية علاج العقم شهرًا واحدًا على الأقل من التحضير. خلال هذه الفترة، تخضع المرأة لتحفيز المبيض باستخدامهرمونات موجهة للغدد التناسلية تليها سحب البويضة عبر المهبل تحت التخدير الموضعي. أظهرت العديد من الدراسات أن التوتر والقلق من الحالات النفسية الشائعة أثناء إجراءات علاج العقم. تتضمن الاستجابات البيولوجية للتوتر تنظيم نشاط الغدد الكظرية. يلعب الكورتيزول، وهو هرمون غلوكورتيكويد يفرز من قشرة الغدة الكظرية، دورًا مهمًا في التنظيم المحلي للمبيض البشري. على سبيل المثال، تم إثبات أن الكورتيزول قد يؤدي إلى موت الخلايا (Granulosa) ، وقد يؤثر على استقلاب الدهون في البويضة. ومع ذلك، فإن تأثير إدارة الإجهاد على جودة البويضة، وتطور الأجنة ، والإخصاب في المختبر (IVF) النتيجة لم تصل إلى توافق في الآراء. تصميم الدراسة ، الحجم ، المدة سيتم إجراءالبحت في عيادة عازوري لأطفال الأنابيب ، مستشفى جبل لبنان. سيتم تنفيذه على الأزواج الذين يخضعون لعمليات التلقيح الصناعي مع دورات حقن الحيوانات المنوية داخل السيتوبلازم. سيتم إجراء دورات التلقيح الصناعي هذه بواسطة الدكتور جوزيف عازوري في اليوم الأول من تنشيط المبيض . سيتم إجراء مقابلات شخصية مع الأزواج المصابين بالعقم للإجابة على استبيان حول تاريخهم الطبي. في موازاة ذلك ، سيتم تقييم مستوى التوتر المدرك باستخدام مقياس الإجهاد المدرك. بعد ذلك ، سيتم تقسيم الأزواج المصابين بالعقم بشكل عشوائي إلى مجموعتين .ستخضع إحدى المجموعات لبرنامج إدارة الإجهاد أثناء علاج العقم. سيكون برنامج إدارة الإجهاد تحت إشراف الدكتور جورج رعد (دكتوراه) ، والسيدة جودي تانيوس (ماجستير) ، والسيدة سيمون كيرباج (ماجستير). في يوم استرجاع البيض ، سيتم تقييم الضغط النفسي للمرضى ، في كلتا المجموعتين ، باستخدام. المشاركون / المواد ، والإعداد ، والطرق بعد استرجاع البويضة، سيتم جمع السائل المسامي. سيتم استخدام المادة الطافية في قياسات الكورتيزول وسيتم حفظ خلايا الحبيبية في الحبيبات لمزيد من التحقيقات الجزيئيةفي مركز الهادي الطبي. علاوة على ذلك، سيتم تحليل جودة البويضة ومورفونيات الجنين وفقًا للإرشادات الدولية من خلال الفحص المجهري الفاصل.
Health conditions/problem studied: Specify
Psychological stress during infertility treatment (specifically IVF)
Interventions: Specify
A randomized controlled trial (RCT) will be conducted at Azoury IVF clinic, Mount-Lebanon hospital. It will be performed on couples undergoing IVF with intra-cytoplasmic sperm injection cycles. These IVF cycles will be conducted by Dr. Joseph Azoury (MD). At the first day of ovarian stimulation using the antagonist protocol (Gonal-f, Cetrotide, and Ovitrelle), in-person interviews will be conducted with infertile couples to answer a questionnaire about their medical history. In parallel, perceived stress level will be evaluated using the Perceived Stress Scale (PSS). Subsequently, the infertile couples will be randomly divided into two groups. One of the groups will be subjected to a stress management program (SMP) during infertility treatment. The stress management program will be under the supervision of Dr.Georges Raad (PhD), Miss Judy Tanios (MSc), and Mrs. Simone Kerbaj (MSc). At the day of egg retrieval, psychological stress of the patients, in both groups, will be assessed using the PSS.
Key inclusion and exclusion criteria: Inclusion criteria
women <38 years old couples undergoing intracytoplasmic sperm injection men with ejaculated sperm couples without psychiatric disorders/treatment
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
21
Key inclusion and exclusion criteria: Age maximum
38
Key inclusion and exclusion criteria: Exclusion criteria
women >39 years old men with testicular biopsy men/women under psychiatric treatment couples with severe male factor
Type of Study
Type
Interventional
Type of intervention
Educations programs
Trial scope
Other
Trial scope: Specify scope
patient education and stress management
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Active
Study phase
0 (explanatory trials)
Study design: Purpose
Supportive care
Study design: Assignment
Parallel
Pharmaceutical class
Not applicable
Therapeutic indication
To reduce IVF-associated stress
Therapeutic benefit
Improving mental health and pregnancy outcomes in infertile patients
Biospecimen retention
Samples without DNA
Biospecimen description
Leftover follicular fluid: for endocrine measurments Leftover Granulosa cells: for cytologic analysis
Target sample size
60
Actual enrollment target size
58
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/09/2018
Date of study closure: Type
Actual
Date of study closure: Date
15/08/2019
Recruitment status
Complete
Date of completion
31/10/2019
IPD sharing statement plan
No
IPD sharing statement description
N/A
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Mount-Lebanon Hospital
OBS-2018-002
Sources of Monetary or Material Support
Name
Azoury IVF clinic, Mount Lebanon Hospital
Secondary Sponsors
Name
Al Hadi medical and laboratory center
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Chadi
Fakih
Haret Hreik
Lebanon
0096176755442
drchsadifakih@yahoo.fr
head of Al hadi center
Scientific
Georges
Raad
Haret Hreik
Lebanon
009613953654
georges.raad@live.com
research associate
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Mount Lebanon Hospital
Joseph Azouri
Gynecology and Obstetrics
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Mount Lebanon Hospital
16/08/2018
Marie Merheb
marie.merheb@mlh.com.lb
+961-5-957 000
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
infertility
In vitro fertilization (Z31.2)
stress, pregnancy, IVF
Interventions
Intervention
Description
Keyword
patient education
RCT
Perceived stress, Ovarian stimulation, follicular fluid, egg quality, embryo morphokinetics
Primary Outcomes
Name
Time points
Measure
Hormonal profile
in the follicular fluid at the time of oocyte aspiration
hormones measurments RIA
Key Secondary Outcomes
Name
Time points
Measure
mental health
before and at the end of the treatment
percieved stress scale
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial