Precision intrauterine contraception may significantly increase continuation of use: a review of long-term clinical experience with frameless copper-releasing intrauterine contraception devices

Figures & data

Figure 1 The mean value in nulliparous and primiparous girls between 15 and 20 years old is ~40–50 cm³.

Note: The red rectangle shows that many adolescents have a small uterus. Reprinted from Ultrasound in Medicine & Biology, Volume 30, Gadelha Da Costa et al, Uterine volume in adolescents, pages 7–10, Copyright © 2004.¹¹

Figure 2 Illustration of how the fundal transverse diameter was measured with a specially designed instrument (cavimeter).

Figure 3 Adapted T-shape intrauterine device with transverse arm of 18 mm.

Table 1 Fundal transverse diameter (mm) according to age and parity (Kurz Cavimetric measurements⁸)

Age	15–19	20–24	25–29	30–34	35–39
Mean ± SD	24.8 ± 2.5	23.9 ± 3.0	24.8 ± 3.2	24.7 ± 3.3	24.9 ± 1.1
No of women	28	221	232	175	96
Parity	0.0	0.1(+)*	1	2	3(+)
Mean ± SD	23.1 ± 3.1	23.8 ± 3.3	24.5 ± 3.0	25.7 ± 3.5	26.0 ± 2.3
No of women	493	124	103	62	13

Note:

* 0.1(+) = no parity, one abortion or more.

Figure 4 (A–C) Geometric relation of a properly inserted intrauterine device (IUD) to endometrial cavities with various inappropriate fundal transverse dimension. (A) Fundal transverse dimension significantly smaller than the length of the transverse arm of the IUD; (B) fundal transverse dimension significantly greater (initial position of the IUD); (C) fundal transverse dimension significantly greater (possible subsequent position of the IUD).

Figure 5 3-D coronal view of the uterine cavity, demonstrating the measurement of the fundal transverse dimension (19.0 mm).

Table 2 Fundal transverse diameter (mm) according to gravidity/parity (3-D measurements)

Gravidity/Parity (n [%])	0 (n = 91)	1 (n = 38)	>1 (n = 81)
0	91 (100.00)	18 (47.3)	3 (3.7)
1		20 (52.6)	9 (11.1)
>1			69 (85.1)
Mean transverse diameter (range)	27.1 (20.2–34.1)	29.6 (22.9–36.3)	31.1 (24.6–37.5)
Mean volume (cm^3) (SD)*	55.3 (25.7)	66.4 (29.2)	103.1 (33.1)

Note:

* The width of the uterine cavity corresponds strongly with the overall uterine volume. Reprinted from Obstetrics and Gynecology, Volume 116, Benacerraf et al, Width of the normal uterine cavity in premenopausal women and effect of parity, pages305–310. Copyright © 2010.¹⁶

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Abbreviation: SD, standard deviation.

Table 3 Number of women, gravidity/parity, and gross cumulative discontinuation rates per 100 users of GyneFix 330 and GyneFix 200 IUDs.

Study Copper surface area (mm^2) Follow-up Interval/postabortal	No of women	% nulligravid/nulliparous	Pregnancy	Expulsion	Removal rate for bleeding/pain
Wildemeersch et al^Citation17 GF390 – 18 months Interval	382	38.5	0.3	0.6	3.1
Van Kets et al^Citation18 GF330 – 36 months Interval	1039	26.7	0.5	0.7	3.8
Wu et al^Citation19,* GF330 – 36 months Interval	302	0.0	0.0	3.0*	4.5
Cao et al^Citation21 GF200 – 60 months Interval	392	24	0.5	0.4	0.8
Batár et al^Citation23 GF330 – 12 months Postabortal up to 10 weeks	112	–	0.0	0.0	5.0
Gbolade^Citation24 GF330 – 1 follow-up in 30 women Postabortal up to 13 weeks	44	–	0.0	0.0	3 removals for bleeding
Martinez et al^Citation25,* GF330 – 12 months Interval	1684	18.6	0.3	5.6*	3.0

Note:

* Majority of investigators were not trained.

Abbreviation: IUD, intrauterine device.

Figure 6 GyneFix 200 (Contrel Europe, Belgium), real size (left), in situ in foam uterus (middle), compared with the frameless FibroPlant-LNG (Contrel Europe, Belgium), which is derived from the frameless copper-releasing intrauterine device (IUD) (right).

Notes: The GyneFix 200 IUD, as used in the clinical trials, consists of four copper sleeves (instead of six with the longer GyneFix 330 IUD), each 5 mm in length and approximately 2.2 mm in diameter. The four copper sleeves are threaded on the polypropylene suture thread, and the uppermost and lowest sleeves are crimped onto it. A single knot is made in the upper portion of the thread, which serves as a small retention body when inserted in the myometrium of the uterine fundus at a controlled depth of 1.0 cm. The minimum effective life of the GyneFix 200 IUD is 5 years. The FibroPlant LNG-IUS is not discussed in this paper.

Figure 7 The current intrauterine device (IUD) is provided with a “visualized” anchor.

Notes: The anchor with visualization element (magnification × 1.5) consists of the anchoring knot and a tiny medical grade stainless steel element (AISI 316L/1.4404) (2 mm long and 0.5 mm in diameter) (left). 2-D and 3-D ultrasound showing the properly located anchor (arrow) as well as the frameless IUD in the uterine cavity of a young woman (middle 2-D and right 3-D).

Figure 8 3-D ultrasonography: Abnormally located ParaGard intrauterine device (IUD) causing bleeding and pain (left) and middle (Mirena). Even if the IUD is apparently located in the correct position, the too-long transverse arm can cause painful contractions (right).

Note: The fundal transverse dimension in these cases (middle and right) is only approximately 2 cm. Adapted from Ultrasound in Obstetrics and Gynaecology, Volume 34, Benacerraf BR, Shipp TD, Bromly B, Three-dimensional ultrasound detection of abnormally located intrauterine contraceptive devices which are the source of pelvic pain and abnormal bleeding, pages 110–115. Copyright © 2009.⁴⁹

Figure 9 2-D/3-D ultrasonography: Position of the stem of the ParaGard intrauterine device (IUD), showing slight downward displacement (left). The arms of the IUD are unfolded and penetrate the muscular wall as the uterus is too small (right).

Note: Although not measured, the fundal transverse diameter appears less than 2 cm. Adapted from Ultrasound in Obstetrics and Gynaecology, Volume 34, Benacerraf BR, Shipp TD, Bromly B, Three-dimensional ultrasound detection of abnormally located intrauterine contraceptive devices which are the source of pelvic pain and abnormal bleeding, pages 110–115. Copyright © 2009.⁴⁹

Figure 10 2-D/3-D ultrasonography: Another example of position of the stem of the Nova-T intrauterine device (IUD), showing slight downward displacement (left). The arms of the IUD are unfolded and penetrate the cornua of the uterus (middle, 3-D; right, hysteroscopy picture).

Note: The fundal transverse diameter is only 22.55 mm.

Figure 11 Mirena: shortened transverse arm after removal because of patient complaints and reinsertion under strict sterile conditions.

Figure 12 3-D ultrasound of GyneFix, illustrating the compatibility of the frameless intrauterine device with very narrow uterine cavities of young adolescent and nulliparous women.

Figure 13 Home Uterine Trainer (HUT), suitable for home training of the frameless intrauterine device and intrauterine system insertion technique.

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