Sexual Dysfunction in Infertile Women With PCOS Undergoing Fertility Treatment
NCT ID: NCT05402800
Last Updated: 2022-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
186 participants
OBSERVATIONAL
2022-01-01
2022-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 .
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Anxiety and Sexual Malfunction Functions in Infertile Pcos Women
NCT05056272
IVF\ICSI Outcome in Women With Polycystic Ovary Syndrome
NCT05756023
Surgical and Non Surgical Treatment Option in Poly Cystic Ovary Cases
NCT05699356
Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome
NCT05661565
Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome
NCT03870035
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 :
1. 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
2. Prolactin level: (1-20 ng/mL)
3. Estradiol level : (ranging from 20-400 pg/mL in healthy normal women)
4. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FSFI questionnaire
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. PCOS.
3. Age from 18-35 years
Exclusion Criteria
2. Refusing participation in study.
3. Other causes of infertility
18 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bassiony Dabian
lecturer of obstetrics and gynecology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kasr Alainy outpatient infertility clinic
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Malin 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.
Ercan 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.
Keye WR Jr. Psychosexual responses to infertility. Clin Obstet Gynecol. 1984 Sep;27(3):760-6. doi: 10.1097/00003081-198409000-00024.
Rotterdam 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12A34
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.