Objective: determining the effect of counseling on sexual and marital satisfaction of infertile couples
Design: randomized clinical trial (RCT) study
Setting: A fertility academic clinic in Tehran, Iran
Patients: 100 infertile couples referring to a Reproductive Health research center
Interventions: 100 infertile couples were randomly allocated into two groups of intervention (50 couples) and control (50 couples). The intervention consisted of three sessions of counseling for 90 minutes each week, and provision of pamphlets. The intervention for each couple was conducted separately.
Main outcome measures: Three questionnaires consisted of demographic characteristics; sexual satisfaction and marital satisfaction were completed through interviews. The outcomes, consisting of changes in sexual satisfaction and marital satisfaction, were compared between the two groups three months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106126777N1
Registration date:2011-08-14, 1390/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-14, 1390/05/23
Registrant information
Name
Minoo Pakgohar
Name of organization / entity
School of Nursing & Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4216
Email address
mpakgohar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2007-02-01, 1385/11/12
Expected recruitment end date
2007-11-19, 1386/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling on marital and sexual satisfaction of infertile couples: A Randomized, Controlled, Trial (RCT) study
Public title
Counseling on quality of marital and sexual satisfaction of infertile couples
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: infertility for 1-10 years, having no children; no previous history of assisted reproductive technologies (ART);not suffering from known mental or physical diseases; not using drugs which affect sexual function and monogamy for men.
Exclusion criteria: positive pregnancy test during sampling and follow-up and attending counseling sessions outside our center
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz blvd., Ghods st.
City
Tehran
Postal code
Approval date
2006-12-26, 1385/10/05
Ethics committee reference number
5845/250
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Sexual satisfaction
Timepoint
Pre test, 3 month after intervention
Method of measurement
Sexual satisfaction questionnare
2
Description
Marital satisfaction
Timepoint
Pre test, 3 month after intervention
Method of measurement
Marital satisfaction questionnare
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, counseling was performed through three sessions of 60-90 minutes duration and one week apart. Each session consisted of a lecture, discussion, questions and answers, and providing educational brochures and pamphlets. In the first session of intervention, definition of infertility, prevalence of infertility, etiologies, therapies and its impacts on various aspects of personal lives, particularly sexual and marital satisfaction, and their counteractive approaches were explained. The purpose of the session was providing general information about the infertility.
The second discussion dealt with behaviors that create marital satisfaction. The ultimate objective was to improve marital satisfaction through teaching communicative skills. These skills, including expression of feelings and emotions, resolving differences, forgiveness, mutual respect and supportive relationship of the couple, listening actively, expressing emotions, particularly about infertility and problem-solving skills such as ability to criticize and accept criticism and establishing a supportive relationship between the couple, were taught in this session.
The third session discussed the influencing factors and approaches for improving sexual satisfaction. The objective of this session was to improve sexual satisfaction through provision of necessary knowledge about male and female sexual cycles and issues such as self-esteem and self-confidence in sexual activities, and the quality and quantity of sexual intercourse.
We planned the counseling sessions, while couples in intervention group had to refer to the clinic for their scheduled medical appointment. So they did not need more visit for consultation meetings.
Category
Other
2
Description
The control group only received the routine therapies and services of the fertility center. No counseling was included for this group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr Reproductive health research center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Research Deputy Dean
Street address
East Nosrat St, Tohid Sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery, Tehran 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
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Minoo Pakgohar
Position
MS.c of Midwifery
Other areas of specialty/work
Street address
Tohid Sq, East Nosrat St.
City
Tehran
Postal code
Phone
+98 912 140 2531
Fax
Email
mpakgohar@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Minoo Pakgohar
Position
lecturer, MS.c of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Sq-east
City
Tehran
Postal code
Phone
+98 912 140 2531
Fax
Email
mpakgohar@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Minoo Pakgohar
Position
lecturer, MS.c of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, East Nosrat St, Tohid Sq
City
Tehran
Postal code
Phone
+98 912 140 2531
Fax
Email
mpakgohar@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)