Comparison of sexual function and satisfaction of infertile women candidate for egg donation in two groups of control and intervention ( Sexual counseling, EXPLISSIT method).
The compare of the sexual function and satisfaction of infertile women, candidates for egg donation in the two group of control and intervention, before, three and eight weeks after the intervention.
Design
A parallel randomized controlled clinical trial on 56 infertile female candidates for egg donation, with sexual dysfunction who are divided in two equal groups of intervention (A) and control(B), by randomized blockade based on 4 blocks.
Settings and conduct
Satisfaction and sexual dysfunction play an important role in the quality of life of many infertile patients and their husbands.This study will be performed on 56 infertile women who are candidates for egg donation with sexual dysfunction at Imam Khomeini Hospital. The samples are randomly divided into four equal groups intervention(A) and control (B). In the intervention group, in addition to routine infertility treatments, the educational intervention will be in the form of individual counseling during four to seven sixty-minute sessions over two months and the control group will receive only routine infertility treatments.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Infertile women candidate for egg donation at fertility age, having sexual dysfunction and absence of physical and mental illness in self and her husband.
exclusion criteria:The presence of any known physical or mental illness in the individual or her husband.
Intervention groups
Intervention group: Infertile women candidates for egg donation with sexual dysfunction, in addition to routine infertility treatments, individual intervention training in 4-7 session for 60 minutes during two months.
Control group: Infertile women who are candidates for egg donation with sexual dysfunction, will receive only routine treatments and will not receive any educational intervention.
Main outcome variables
Sexual function
Sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191204045607N1
Registration date:2019-12-10, 1398/09/19
Registration timing:prospective
Last update:2019-12-10, 1398/09/19
Update count:0
Registration date
2019-12-10, 1398/09/19
Registrant information
Name
Maryam Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
m_bagheri@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sexual function and satisfaction of infertile women candidate for egg donation in two groups of control and intervention ( Sexual counseling, EXPLISSIT method).
Public title
Effect of sexual counseling on sexual function and satisfaction in infertile candidates for egg donation.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
reproductive age
Infertile woman that the need of egg donation for fertility confirms by an infertility specialist
stable life with her husband (not on the verge of divorce).
Sexual dysfunction, score of 26.5 and lower in the female sexual function index questionnaire
Lack of sexual problem or debilitating illness in husband
Lack of known mental illness and use of Psychiatric drugs drugs (all patients receive psychiatric consultation).
Lack of herbal and hormonal drugs or drugs that affect sexual function, according to the patient statement
Access to her for at least the next three months
Exclusion criteria:
Occurrence of any known physical or mental on patient or her husband
irregular attending to counseling sessions
The occurrence of pregnancy during the study
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
56 infertile women who are candidates for egg donation are randomly divided into four equal groups (intervention) and control (B). As all possible modes are considered to be the letters A and B in quadruple blocks having a total of six modes, these six modes are numbered 1 through 6 and the number of blocks required is 4 The basis of the sample number will be determined.So we will have 14 blocks of four.Then the number of random blocks are arranged on the basis of random number table.For example, according to ABBA / ABAB the fourth person falls into the intervention group or A.
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 Tehran University of Medical Sciences
Before the Intervention, three and eight weeks after the intervention
Method of measurement
Female Sexual Function Index (FSFI) Questionnaire
2
Description
Sexual satisfaction
Timepoint
Before the Intervention, three and eight weeks after the intervention
Method of measurement
Index of sexual Satisfaction(ISS) Questionnaire
Secondary outcomes
1
Description
Depression, Anxiety,Stress
Timepoint
Before the Intervention, three and eight weeks after the intervention
Method of measurement
Depression- Anxiety- Stress Scale questionnaire
Intervention groups
1
Description
Intervention group: In addition to routine infertility treatments, sex counseling sessions for this group are based on the EX-PLISSIT model (opportunity to express sexual questions and concerns at each stage of education) for each patient individually in 4-7 sessions of 60 to 90 minutes. It will be held weekly in the infertility clinic of Imam Khomeini Hospital in Tehran.
Category
Behavior
2
Description
Control group: The control group will receive no intervention during the study, and only routine infertility treatments will be provided.