NCT05402800

Brief 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 . 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 29, 2022

Last Update Submit

May 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of sexual dysfunction in PCOS

    prevalence of sexual dysfunction in PCOS

    6 months

Secondary Outcomes (2)

  • Risk factors for sexual dysfunction in PCO

    6 months

  • Relation of sexual dysfunction to different fertility treatments in PCO

    6 months

Interventions

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

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Infertility .
  • PCOS.
  • Age from 18-35 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy outpatient infertility clinic

Cairo, Egypt

RECRUITING

Related Publications (6)

  • 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

    BACKGROUND
  • 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.

    PMID: 12407062BACKGROUND
  • 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.

    PMID: 11380158BACKGROUND
  • 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.

    PMID: 23407282BACKGROUND
  • Keye WR Jr. Psychosexual responses to infertility. Clin Obstet Gynecol. 1984 Sep;27(3):760-6. doi: 10.1097/00003081-198409000-00024.

    PMID: 6488617BACKGROUND
  • 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.

    PMID: 14711538BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

May 29, 2022

First Posted

June 2, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations