This is a randomized clinical trial(RCT) study will conduct on qualified infertile women in the Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol University of Medical Sciences in 2014-2015 years after the approval of the Ethics Committee. Informed consent will obtain from each woman participant before enrolling in the study. The subjects will complete the Female Sexual Function Index (FSFI), Beck Depression Inventory (BDI), Spielberger State-Trait Anxiety Inventory (STAI), General health questionnaire (GHQ), Pittsburgh Sleep Quality Index (PSQI), Couple Burnout Measurement (CBM), and Body Image Assessment before and after interventions. A psychologist will conduct a clinical interview based on the diagnostic criteria of DSM-V. After identifying 99 infertile women with sexual dysfunction and without severe depression, the subjects were randomized to three groups of 33 each as follows: 1-psycho-sexual therapy group: This group will participate in a two-hour group session for 10 weeks. Each group consists of 8–12 members. Therapeutic model is a combination of mind fullness-Based cognitive therapy and sexual skills. Sexual behavioral program is based on Crowe and Ridley model. 2-pharmacotherapy group: Subjects will take a tablet of Bupropion SR (150 mg) daily (evening) (manufactured by D Abidi plant) for two months after the interview by a psychiatrist. 3- Control group: Participants will complete questionnaires at the beginning of the study and two months afterward. In order to observe the ethics of research, members of this group will be referred to sex therapy clinic at the end of two months of treatment.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015042721955N2
Registration date:2015-08-02, 1394/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-02, 1394/05/11
Registrant information
Name
Hajar Pasha
Name of organization / entity
Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0597
Email address
hpasha@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2015-08-01, 1394/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the effect psycho-sexual therapy and pharmacotherapy Bupropion interventions on improvement of sexual function in infertile women
Public title
A Comparison psycho-sexual therapy and pharmacotherapy Bupropion interventions on improvement of sexual function in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: The less or equal score of 26.55 from Female Sexual Function Index(FSFI); The final diagnosis with clinical interview is based on DSM-V criteria by psychologist; duration of infertility more than 1 year; women infertile who did not decide to undergo fertility treatment until 2 months afterward; aged between 15-45 years; ability to read and to write; having a stable sexual activity(at least for recent four weeks); availability of the husband; no remarrying of couples; no history of sterilization; no foster child. Exclusion criteria included: drug abuse; severe psychiatric disorders(major depression, bipolar disorder, patients with suicidal idea or psychosis); history of physical illness(diabetes mellitus, cardiovascular diseases, hypertension, hyperthyroidism, hypothyroidism, epilepsy, hepatic dysfunction); physical problems(spinal cord injury, limb deformity); mental health problems under the treatment of a physician; drugs consumers causing sexual dysfunction such as barbiturates, benzodiazepines , antidepressants, ant hypertensions; having psychological support( psychotherapy sessions, relaxation techniques, yoga ); experiencing a stressful event in the past three months(death or serious illness in the family, a major change in living conditions).
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
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
The Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrouze Street, Mazandaran Province, Iran
City
Babol
Postal code
4717647745
Approval date
2014-12-10, 1393/09/19
Ethics committee reference number
4930
Health conditions studied
1
Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
sexual function
Timepoint
Before and two months after of intervention
Method of measurement
Female Sexual Function Index (FSFI), and clinical interview based on the diagnostic criteria of DSM-V.
Secondary outcomes
1
Description
Depression, Anxiety, General health, Sleep Quality, Couple Burnout, Body Image
Timepoint
Before and two months after of intervention
Method of measurement
Beck Depression Inventory (BDI), Spielberger State-Trait Anxiety Inventory (STAI), General health questionnaire (GHQ), Pittsburgh Sleep Quality Index (PSQI), Couple Burnout Measurement (CBM), and Body Image Assessment, and clinical interview based on the diagnostic criteria of DSM-V
Intervention groups
1
Description
Psycho-sexual therapy group: This group will participate in a two-hour group session for 10 weeks. Each group consists of 8–12 members. Therapeutic model is a combination of mind fullness-Based cognitive therapy and sexual skills. Sexual behavioral program is based on Crowe and Ridley model.
Category
Treatment - Other
2
Description
Pharmacotherapy group: This group will take a tablet of Bupropion SR (150 mg) daily (evening) (manufactured by D Abidi plant) for two months by a psychiatrist. Subjects will receive 30 tablets after the interview, and will refer to center monthly to receive their medication. Duration of treatment will be two months.
Category
Treatment - Drugs
3
Description
Control group: Participants in this group will complete questionnaires at the beginning of the study and two months afterward. In order to observe the ethics of research, members of this group will be referred to sex therapy clinic at the end of two months of treatment. All groups will complete questionnaires in the beginning and ending of the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol of Medical Science
Full name of responsible person
Hajar Pasha
Street address
Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol University of Medical Sciences, Tork Mahalleh, Babol, Mazandaran province, Iran
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences, Ganjafrouze Street, Mazandaran Province, Iran
City
Babol
Grant name
387-12 مورخ 6/8/1393
Grant code / Reference number
2385
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Hajar Pasha
Position
Assistant Professor of Babol University of Medical Sciences, Midwife (MSc)
Other areas of specialty/work
Street address
Midwifery Department, Babol University of Medical Sciences, Ganjafrouze Street, Mazandaran Province, Iran
Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol University of Medic
Full name of responsible person
Zahra Basirat
Position
Gynocologist and Professor of Babol University of Medical Sciences
Other areas of specialty/work
Street address
Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol University of Medical Sciences, Tork Mahalleh, Babol, Mazandaran province, Iran
City
Babol
Postal code
4717647745
Phone
+98 11 3219 0597
Fax
+98 11 3219 9936
Email
basiratzahra@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol University of Medic
Full name of responsible person
Hajar Pasha
Position
Midwife(MSc), Assistant Professor of Babol University of Medical Sciences
Other areas of specialty/work
Street address
Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol University of Medical Sciences, Tork Mahalleh, Babol, Mazandaran province, Iran