Sexual DysfunctionNCT05402800
Sexual Dysfunction in Infertile Women With PCOS Undergoing Fertility Treatment
An observational study of Sexual Dysfunction and PCOS, run by Cairo University at 1 site in Egypt.
Trial summary
Infertility, defined as the inability to become pregnant after one year of regular unprotected sexual intercourse. It is estimated that around 20 % of couples suffer from infertility with prevalence rates of infertility differing substantial among countries . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, PCOS
- What is being tested?
- FSFI questionnaire
- How many people
- 186 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients aged 18-35 were recruited from Kasr Al-Ainy Gynecology Clinic (Infertility Clinic) Medicine Hospital, Faculty of Medicine, Cairo University. They were diagnosed with primary infertility and polycystic ovary by Rotterdam criteria (8). Patients with medical conditions (apart from PCOS complications like type II diabetes, obesity and metabolic syndrome) or receiving antidepressant therapy were excluded. Females with other causes of infertility associated with PCOS (e.g uterine factors, tubal factors) were not included. Patients with history of psychotic disorders or substance abuse were excluded
Who may be able to join
- Infertility .
- PCOS.
- Age from 18-35 years
Who cannot join
- chronic medical condition previously associated with FSD (e.g. diabetes mellitus and cardiovascular diseases, such as hypertension) or using antidepressant medications.
- Refusing participation in study.
- Other causes of infertility
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy outpatient infertility clinic
Cairo
bassiony dabian, MD, 1095195513, bassiony.dabian@gmail.com
About this study
Infertility, defined as the inability to become pregnant after one year of regular unprotected sexual intercourse. It is estimated that around 20 % of couples suffer from infertility with prevalence rates of infertility differing substantial among countries .
Sexual function in females is very complex and is affected by many factors. The prevalence of sexual dysfunction is higher in infertile patients compared to the normal population .
Whether sexual dysfunction is the cause or consequence of subfertility is difficult to establish. For instance, sexual dysfunction might result in decreased coital frequency compounding the issue of subfertility due to reduced exposure. On the other hand, the psychological pressure to get pregnant stemming from sex on demand could result in a reduction in enjoyment of sex aggravating sexual dysfunction. Indeed, situational sexual dysfunction and loss of a couple's intimacy may occur as a consequence of timed intercourse where focus for coitus is no longer pleasure but conception .
Read the detailed description
Our work is an observational analytic cross-sectional study that included an Egyptian convenient sample of 186 females with primary infertility due to polycystic ovary syndrome.
Patients aged 18-35 were recruited from Kasr Al-Ainy Gynecology Clinic (Infertility Clinic) Medicine Hospital, Faculty of Medicine, Cairo University. They were diagnosed with primary infertility and polycystic ovary by Rotterdam criteria .
Patients with medical conditions (apart from PCOS complications like type II diabetes, obesity and metabolic syndrome) or receiving antidepressant therapy were excluded. Females with other causes of infertility associated with PCOS (e.g uterine factors, tubal factors) were not included. Patients with history of psychotic disorders or substance abuse were excluded. All patients approved to participate in the study and signed an informed consent to confirm this approval.
Intervention :
A- Gynecological Assessment :
Using Kasr Al Ainy infertility sheet that include clinical history taking of amenorrhea or oligomenorrhea. assessment of age years and type of infertility, medical history, surgical history, weight , height, history of hirsutism, ultrasound finding, speculum examination and hormonal profile including (FSH, LH, E2, Prolactin, TSH and progesterone) also history of any surgical intervention and type of fertility treatment were obtained . Vaginal ultrasound and speculum examination were done to every patient. PCOS was diagnosed using Rotterdam criteria based on identifying at least two of the following three features: oligo/anovulation , hyperandrogenism: clinical (hirsutism or male pattern alopecia) or biochemical (raised free androgen index or free testosterone) \& polycystic ovaries on ultrasound (a follicle number per ovary of > 10).
Other etiologies must be excluded such as congenital adrenal hyperplasia, androgen secreting tumours, Cushing syndrome, thyroid dysfunction and hyperprolactinaemia .
Laboratory work up including :
- LH/FSH ratio: Many women with PCOS have LH and FSH levels still within the 5-20 mlU/ml range, but their LH level is often two or three times that of the FSH level
- Prolactin level: (1-20 ng/mL)
- Estradiol level : (ranging from 20-400 pg/mL in healthy normal women)
- TSH level : (normally 0.35- 5 μU/mL). TSH is checked to rule out other problems, such as an underactive or overactive thyroid, which often cause irregular or lack of periods and anovulation .
All blood samples (FSH-LH- E2 -PRL-TSH) were obtained at the second day of menstrual cycle in all women within the last six months before the interview
B-Data collection tool was a questionnaire completed through interviews in private meetings by the researcher. The questionnaire was composed of two parts: demographic characteristics and information about sexual relationship (such as frequency of sexual contacts per week, satisfaction with sexual and non-sexual relationships). Sexual dysfunction measurement were done by gynecologists/sexologists in infertility center on the basis of a diagnostic interview according to the Female Sexual Functioning Index (FSFI) The FSFI is a reliable test for the assessment of sexual function in women. The Arabic version of this test, was used. The FSFI is comprised of six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) with score ranges of 0 (or 1) to 5. The total FSFI score ranges from 2.0 to 36. The translated version of the FSFI test was used in this study. All questions in the FSFI questionnaire were explained by the physician one by one, and they were filled in a suitable and silent environment where patients could comfortably share such intimate information.
Analysis of data will be done by using SPSS ( statistical program for social science version 23 ) . Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using (Mann Whitney U ) test for independent samples while categorical data will be compared using ( Chi squared test ) or ( Fisher exact test ) when appropriate.
Correlation coefficient test will be used to rank different variables against each other where a probability value (p value) > 0.05 will be considered statistically insignificant , a probability value (p value) < 0.05 will be considered statistically significant \& a probability value (p value) < 0.001 will be considered statistically highly significant.
- Conditions
- Sexual Dysfunction, PCOS
- Being tested
- FSFI questionnaire
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSFI questionnaireOther
The FSFI is a reliable test for the assessment of sexual function in women. The Arabic version of this test, was used. The FSFI is comprised of six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) with score ranges of 0 (or 1) to 5. The total FSFI score ranges from 2.0 to 36. The translated version of the FSFI test was used in this study. All questions in the FSFI questionnaire were explained by the physician one by one, and they were filled in a suitable and silent environment where patients could comfortably share such intimate information
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of sexual dysfunction in PCOS
prevalence of sexual dysfunction in PCOS
Measured: 6 months
Secondary outcomes (2)
Risk factors for sexual dysfunction in PCO
Risk factors for sexual dysfunction in PCO
Measured: 6 months
Relation of sexual dysfunction to different fertility treatments in PCO
Relation of sexual dysfunction to different fertility treatments in PCO
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassiony Dabian, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402800
- Sponsor's protocol ID
- 12A34
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
World Health Organization. Report of a WHO meeting. In: Vayena E, Rowe PJ, Griffin PD, editors. Current practices and controversies in assisted reproduction. Geneva: Byword Editorial Consultants; 2002. p. 1-396
Fassino S, Piero A, Boggio S, Piccioni V, Garzaro L. Anxiety, depression and anger suppression in infertile couples: a controlled study. Hum Reprod. 2002 Nov;17(11):2986-94. doi: 10.1093/humrep/17.11.2986.
PubMed 12407062Malin M, Hemmink E, Raikkonen O, Sihvo S, Perala ML. What do women want? Women's experiences of infertility treatment. Soc Sci Med. 2001 Jul;53(1):123-33. doi: 10.1016/s0277-9536(00)00317-8.
PubMed 11380158Ercan CM, Coksuer H, Aydogan U, Alanbay I, Keskin U, Karasahin KE, Baser I. Sexual dysfunction assessment and hormonal correlations in patients with polycystic ovary syndrome. Int J Impot Res. 2013 Jul-Aug;25(4):127-32. doi: 10.1038/ijir.2013.2. Epub 2013 Feb 14.
PubMed 23407282Keye WR Jr. Psychosexual responses to infertility. Clin Obstet Gynecol. 1984 Sep;27(3):760-6. doi: 10.1097/00003081-198409000-00024.
PubMed 6488617Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
PubMed 14711538
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction in Infertile Women With PCOS Undergoing Fertility Treatment
- ClinicalTrials.gov ID
- NCT05402800
- Acronym / sponsor ID
- 12A34
- Conditions
- Sexual Dysfunction, PCOS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infertility, defined as the inability to become pregnant after one year of regular unprotected sexual intercourse. It is estimated that around 20 % of couples suffer from infertility with prevalence rates of infertility differing substantial among countries .
Sexual function in females is very complex and is affected by many factors. The prevalence of sexual dysfunction is higher in infertile patients compared to the normal population .
Whether sexual dysfunction is the cause or consequence of subfertility is difficult to establish. For instance, sexual dysfunction might result in decreased coital frequency compounding the issue of subfertility due to reduced exposure. On the other hand, the psychological pressure to get pregnant stemming from sex on demand could result in a reduction in enjoyment of sex aggravating sexual dysfunction. Indeed, situational sexual dysfunction and loss of a couple's intimacy may occur as a consequence of timed intercourse where focus for coitus is no longer pleasure but conception .
Detailed description
Our work is an observational analytic cross-sectional study that included an Egyptian convenient sample of 186 females with primary infertility due to polycystic ovary syndrome.
Patients aged 18-35 were recruited from Kasr Al-Ainy Gynecology Clinic (Infertility Clinic) Medicine Hospital, Faculty of Medicine, Cairo University. They were diagnosed with primary infertility and polycystic ovary by Rotterdam criteria .
Patients with medical conditions (apart from PCOS complications like type II diabetes, obesity and metabolic syndrome) or receiving antidepressant therapy were excluded. Females with other causes of infertility associated with PCOS (e.g uterine factors, tubal factors) were not included. Patients with history of psychotic disorders or substance abuse were excluded. All patients approved to participate in the study and signed an informed consent to confirm this approval.
Intervention :
A- Gynecological Assessment :
Using Kasr Al Ainy infertility sheet that include clinical history taking of amenorrhea or oligomenorrhea. assessment of age years and type of infertility, medical history, surgical history, weight , height, history of hirsutism, ultrasound finding, speculum examination and hormonal profile including (FSH, LH, E2, Prolactin, TSH and progesterone) also history of any surgical intervention and type of fertility treatment were obtained . Vaginal ultrasound and speculum examination were done to every patient. PCOS was diagnosed using Rotterdam criteria based on identifying at least two of the following three features: oligo/anovulation , hyperandrogenism: clinical (hirsutism or male pattern alopecia) or biochemical (raised free androgen index or free testosterone) \& polycystic ovaries on ultrasound (a follicle number per ovary of > 10).
Other etiologies must be excluded such as congenital adrenal hyperplasia, androgen secreting tumours, Cushing syndrome, thyroid dysfunction and hyperprolactinaemia .
Laboratory work up including :
- LH/FSH ratio: Many women with PCOS have LH and FSH levels still within the 5-20 mlU/ml range, but their LH level is often two or three times that of the FSH level
- Prolactin level: (1-20 ng/mL)
- Estradiol level : (ranging from 20-400 pg/mL in healthy normal women)
- TSH level : (normally 0.35- 5 μU/mL). TSH is checked to rule out other problems, such as an underactive or overactive thyroid, which often cause irregular or lack of periods and anovulation .
All blood samples (FSH-LH- E2 -PRL-TSH) were obtained at the second day of menstrual cycle in all women within the last six months before the interview
B-Data collection tool was a questionnaire completed through interviews in private meetings by the researcher. The questionnaire was composed of two parts: demographic characteristics and information about sexual relationship (such as frequency of sexual contacts per week, satisfaction with sexual and non-sexual relationships). Sexual dysfunction measurement were done by gynecologists/sexologists in infertility center on the basis of a diagnostic interview according to the Female Sexual Functioning Index (FSFI) The FSFI is a reliable test for the assessment of sexual function in women. The Arabic version of this test, was used. The FSFI is comprised of six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) with score ranges of 0 (or 1) to 5. The total FSFI score ranges from 2.0 to 36. The translated version of the FSFI test was used in this study. All questions in the FSFI questionnaire were explained by the physician one by one, and they were filled in a suitable and silent environment where patients could comfortably share such intimate information.
Analysis of data will be done by using SPSS ( statistical program for social science version 23 ) . Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using (Mann Whitney U ) test for independent samples while categorical data will be compared using ( Chi squared test ) or ( Fisher exact test ) when appropriate.
Correlation coefficient test will be used to rank different variables against each other where a probability value (p value) > 0.05 will be considered statistically insignificant , a probability value (p value) < 0.05 will be considered statistically significant \& a probability value (p value) < 0.001 will be considered statistically highly significant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients aged 18-35 were recruited from Kasr Al-Ainy Gynecology Clinic (Infertility Clinic) Medicine Hospital, Faculty of Medicine, Cairo University. They were diagnosed with primary infertility and polycystic ovary by Rotterdam criteria (8). Patients with medical conditions (apart from PCOS complications like type II diabetes, obesity and metabolic syndrome) or receiving antidepressant therapy were excluded. Females with other causes of infertility associated with PCOS (e.g uterine factors, tubal factors) were not included. Patients with history of psychotic disorders or substance abuse were excluded
Key inclusion criteria (3 listed)
- Infertility .
- PCOS.
- Age from 18-35 years
Key exclusion criteria (3 listed)
- chronic medical condition previously associated with FSD (e.g. diabetes mellitus and cardiovascular diseases, such as hypertension) or using antidepressant medications.
- Refusing participation in study.
- Other causes of infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSFI questionnaireThe FSFI is a reliable test for the assessment of sexual function in women. The Arabic version of this test, was used. The FSFI is comprised of six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) with score ranges of 0 (or 1) to 5. The total FSFI score ranges from 2.0 to 36. The translated version of the FSFI test was used in this study. All questions in the FSFI questionnaire were explained by the physician one by one, and they were filled in a suitable and silent environment where patients could comfortably share such intimate information | Other | – |
Primary outcome
prevalence of sexual dysfunction in PCOS
Time frame: 6 months
prevalence of sexual dysfunction in PCOS
2 secondary outcomes
Risk factors for sexual dysfunction in PCO
Time frame: 6 months
Relation of sexual dysfunction to different fertility treatments in PCO
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- BackgroundWorld Health Organization. Report of a WHO meeting. In: Vayena E, Rowe PJ, Griffin PD, editors. Current practices and controversies in assisted reproduction. Geneva: Byword Editorial Consultants; 2002. p. 1-396
- Background: PubMed 12407062Fassino S, Piero A, Boggio S, Piccioni V, Garzaro L. Anxiety, depression and anger suppression in infertile couples: a controlled study. Hum Reprod. 2002 Nov;17(11):2986-94. doi: 10.1093/humrep/17.11.2986.
- Background: PubMed 11380158Malin M, Hemmink E, Raikkonen O, Sihvo S, Perala ML. What do women want? Women's experiences of infertility treatment. Soc Sci Med. 2001 Jul;53(1):123-33. doi: 10.1016/s0277-9536(00)00317-8.
- Background: PubMed 23407282Ercan CM, Coksuer H, Aydogan U, Alanbay I, Keskin U, Karasahin KE, Baser I. Sexual dysfunction assessment and hormonal correlations in patients with polycystic ovary syndrome. Int J Impot Res. 2013 Jul-Aug;25(4):127-32. doi: 10.1038/ijir.2013.2. Epub 2013 Feb 14.
- Background: PubMed 6488617Keye WR Jr. Psychosexual responses to infertility. Clin Obstet Gynecol. 1984 Sep;27(3):760-6. doi: 10.1097/00003081-198409000-00024.
- Background: PubMed 14711538Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction and PCOS, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of sexual dysfunction in PCOS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402800, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.