An interventional study of questionnaire in Premature Ovarian Failure, sponsored by University Hospital, Bordeaux. Completed at 2 sites in France. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
The aim of this study is to evaluate the evolution of quality of sex life of women with POI after introduction hormone replacement therapy through the FSFI scale
Premature ovarian failure (POI) is a pathology that affects about 1-2% of women before the age of 40. The resulting estrogen deficiency is the cause of multiple repercussions. Clinically, sexual disorders may appear in the short term, such as a decrease in libido, vaginal dryness, an increase in dyspareunia, resulting in less frequent sexual intercourse and less satisfaction with sexual life. The quality of life of these patients also appears to be reduced compared to women with normal ovarian reserve. A 2008 study showed that the sexual function of patients with POI treated with hormone replacement therapy (HRT) was normal but remained significantly lower than that of patients with normal ovarian function. However, no study has attempted to assess the evolution of the symptomatology of these patients before and after the introduction of HRT. Evidence of improvement in sexual disorders under treatment could be an additional argument to improve patient adherence and treatment compliance; as well as information for health professionals
181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.
This study's enrollment of 72 is above the median of 48 across 113 interventional studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
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Female Sexual Function Index (FSFI) and WHO Quality of Life-BREF (WHOQOL-BREF) questionnaires at baseline and at 6 months after starting hormone replacement therapy.
Other: questionnaire
Female Sexual Function Index (FSFI) and WHO Quality of Life-BREF (WHOQOL-BREF) questionnaires at baseline and 6 months after starting hormone replacement therapy
FSFI questionnaire score
This is a self-assessment questionnaire with 19 items. It considers 6 domains of female sexuality: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). The items are rated on a 0 or 1 to 5 point scale (low score of 0-1 to high score of 5) to determine a raw score per domain. Then, the score for each domain is multiplied by a standardised coefficient to arrive at a total score between 2 and 36. The cut-off point for differentiating between women with and without sexual problems is 26.55; a lower score reflects the existence of sexual problems.
Time frame: Month 6
FSFI score according to the aetiology and to the mode of administration of hormonal treatment
FSFI score before and after 6 months of treatment according to the aetiology of Premature ovarian failure (POI) (idiopathic, genetic, iatrogenic, Turner syndrome) and according to the mode of administration of hormonal treatment
Time frame: Baseline, Month 6
WHOQOL-BREF score
The WHOQOL-BREF questionnaire is a self-assessment questionnaire with 26 items and has been used to study the quality of life of patients with POI. The WHOQOL-BREF is the short version of the WHOQOL and addresses 4 domains of quality of life: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall quality of life and general health. The items are evaluated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw score per item. Next, the average score for each domain is calculated, resulting in an average domain score between 4 and 20. Finally, this average domain score is then multiplied by 4 to transform the domain score into a scaled score (comparable to the score used in the original WHOQOL-100), with a higher score indicating a better quality of life
Time frame: Baseline, Month 6
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in Apr 2026, 32 months.
Of 24 interventional studies with no phase under Primary Ovarian Insufficiency, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 68. This study's 32 months is below that.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Primary Ovarian Insufficiency →
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