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RCOG World Congress 2025
June 23 - 25, 2025 | ExCeL London, UK
EP.1309
Yanae®: a painless alternative for successful IUD insertion – Final clinical trial results
Poster Presenter
Authors
Sharad Singh, Anjoo Agarwal, Deepali Srivastav, Renu Singh, Vanita Jain, Bharti Joshi, Raman Bansal, Kalpana Mahadik, Razia Sultana, Richa Singh, Henri Mathé, Clémence Desjardin, Victoria Michaels Lopez, André Ulmann
Affiliations
Pregna International Limited, King George’s Medical University U.P., Institutional ethics Committee, Postgraduate Institute of Medical Education & Research Chandigarh Institutional Collaborative Research Committee, Ruxmaniben Deepchand Gardi Medical Collage, Institutional ethics Committee S. N. Medical Collage, CEMAG Care
Part of Topic
Innovation in obstetrics and gynaecology
Video
Yanae : a painless alternative for successful IUD insertion – Final clinical trial results
BACKGROUND
A significant barrier to IUD adoption is the pain and discomfort associated with insertion. Conventional insertion techniques, involving cervical traction with a tenaculum and uterine sounding, can cause pain, anxiety, and bleeding [1]. Additionally, rigid IUD insertors often fail to adapt to the cervical canal's shape, exacerbating discomfort. Studies evaluating women's pain during these stages of IUD insertion report moderate pain levels during tenaculum placement, sounding and IUD insertion [2,3].
In collaboration with CrossBay (US), CEMAG Care (France) has developed an innovative insertor combined with a copper IUD, called Yanae®. This specific insertor has a flexible inflatable membrane allowing self-guided, atraumatic, to facilitate the cervical crossing (Fig. 1).
OBJECTIVES AND DESIGN
A prospective, multicentre, open-label, single-arm study conducted across four distinct clinical sites or medical Institutes in India.
Primary objective: Evaluate the efficacy of intrauterine device (IUD) insertion with Yanae®.
Secondary objective:
Additional objective:
METHODS
Women desiring long-term contraception were invited to participate from participating sites. IUD insertion was performed according to Yanae® instructions for use (Fig. 2).
The efficacy of IUD insertion with Yanae® was assessed based on successful insertion and correct fundal placement, confirmed by ultrasound immediately post-insertion. The necessity for additional instruments such as uterine sound or tenaculum / vulsellum was also recorded.
Pain levels experienced by participants were evaluated using a Visual Analog Scale (VAS-10cm).
Participant and provider satisfaction was self-rated using a qualitative scale from Dissatisfied to Very satisfied.
RESULTS
This study enrolled 167 women (median age 31 years), with 99.4% being multiparous and 34.1% had previously used IUD as contraception method.
1-Successful insertion was achieved in 99.4% of cases
The success rate of the insertion procedure was measured by three parameters –device preparation, insertion procedure and device placement.
Out of 167 participants, the study device, Yanae® enabled successful IUD insertion and correct placement in 166 women (99.4%) (Fig.3).
In one case (0.4%), insertion failed after two attempts despite vulsellum use due to an impassable cervix.
Ultrasound measurements showed a median fundal distance of 3 mm from the superior edge of the IUD (vertical arm) to the internal endometrial verge.
2-Ease of IUD insertion using Yanae®
3-Pain reported by participants is minimal : mean score of 1.5 on a 10 cm Visual Analogue Scale (VAS)
Among the 166 participants who successfully received IUD insertion, the Yanae® device was well-tolerated, with very low pain levels reported.
4-Both HCPs and participants express very high level of satisfaction
156 participants (93.9%) reported high satisfaction, and healthcare providers reported high satisfaction in 161 cases (96.9%).
Furthermore, 92.2% of participants indicated that they would recommend Yanae® to others.
“Yanae is a novel and convenient copper IUD. Insertion process being less painful made it more woman compliant and acceptable”.
Prof. Richa Singh, S. N. Medical College, Agra
CONCLUSION
This multicenter study confirms that Yanae® device offers a safe, effective, and well-tolerated approach to IUD insertion, significantly reducing procedural pain and enhancing both user and provider satisfaction. This innovative technique has the potential to promote wider adoption of IUDs for long-term contraception.
REFERENCES
[1] Doty N, MacIsaac L. Effect of an atraumatic vulsellum versus a single-tooth tenaculum on pain perception during intrauterine device insertion: a randomized controlled trial. Contraception. 2015;92(6):567–571.
[2] Rapkin RB, Achilles SL, Schwarz EB, et al. Self-Administered Lidocaine Gel for Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2016;128(3):621–628.
[3] Akers AY, Steinway C, Sonalkar S, et al. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017;130(4):795–802.
[4] Gemzell‐Danielsson K, Jensen JT, Monteiro I, et al. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019;98(12):1500–1513.
[5] Akintomide H, Brima N, Sewell RDE, et al. Patients’ experiences and providers’ observations on pain during intrauterine device insertion. Eur J Contracept Reprod Health Care. 2015;20(4):319–326.