Friday, July 31, 2009

GyneFix IUD Efficacy


A Mini-GyneFix IUD similar to the one Cyndi has inserted

Title: GyneFix IUD Efficacy Labels: GyneFix, ParaGard, IUD, Frameless Copper IUD, Conventional IUD, TCu380A.

MONTHLY WOMEN'S HEALTH RESEARCH REVIEW
RESEARCH Study Compares Efficacy of Frameless Copper IUD, Conventional IUD, [July 31, 2009]

Summary of "The Frameless Copper IUD (GyneFix) and the TCu380A IUD: Results of an Eight-Year Multicenter Randomized Comparative Trial," Meirik et al., Contraception, August 2009.

Women often discontinue use of intrauterine devices because of pain, bleeding or a combination of the two. Those side effects usually are linked to the frame and size of the IUDs, which prompted the production of GyneFix, a frameless copper IUD, in the mid-1980s. In 1989, the World Health Organization's Special Program of Research, Development and Research Training in Human Reproduction launched a multicenter, randomized comparative trial of GyneFix and the conventional T-shaped TCu380A IUD (Meirik et al., Contraception, August 2009). A frameless IUD does not have a plastic frame holding it together. It instead is composed of copper cylinders tied together by a nylon thread, which is then anchored into the uterus (O'Brien/Marfleet, Cochrane Collaboration, November 2004).

Methods: Researchers from Chile, France, Sweden and Switzerland recruited women at 21 centers in Brazil, Chile, China, Hungary, Mexico, the Philippines, Slovenia and Thailand. To qualify to participate in the study, the women had to be healthy; between ages 16 and 40; had at least one previous pregnancy that lasted until at least 20 weeks' gestation; or delivered a fetus that weighed more than 500 grams.

Women who visited family planning clinics and opted for IUDs as a form of contraception were informed about the study. The women were required to agree to follow-up exams at regular intervals through 2001. Altogether, 4,063 women were considered eligible and agreed to participate. The researchers then used a randomization procedure to allocate frameless IUDs to 2,027 women and the TCu380A IUD to 2,036 women. IUD insertions occurred from November 1988 to September 1993, and the eight-year follow-up period was completed in September 2001.

All the women were asked to consult with the clinic if they experienced any problems with the IUDs or wanted them removed. If the women experienced any side effects or were urged to have it removed for medical reasons, the device was removed and these women were not required to return for follow-up exams.

Results: The study found 43 insertion failures with the frameless IUD and none with the TCu380A. In the first year, the expulsion rate of the frameless IUD was 5.3 per 100 women and 2.5 per 100 for the TCu380A. There was no difference in expulsion rates from the second through eighth year. The study also found that the first-year pregnancy rate for the frameless IUD was 1.3 pregnancies per 100 women and 0.5 for the TCu380A. In the second- through eighth-year period, the pregnancy rate was 1.2 for the frameless IUD and 2.5 for the TCu380A.

The study also found that the eight-year cumulative rate of ectopic pregnancy for the frameless IUD was 0.1 per 100 women years, compared with 0.5 for the TCu380A device. The researchers found that the eight-year cumulative rate for IUD removal due to pain was lower for the frameless IUD than for the TCu380A. The researchers found that IUD removals for other reasons were not different between the two devices.

Conclusion: The researchers found that the long-term clinical efficacy of the frameless IUD was similar to that of the TCu380A. In some instances, the conventional devices worked better than in others. For example, the frameless IUD had more insertion failures, expulsions and pregnancies during the first year of use compared with the TCu380A. However, women with the frameless device reported fewer pregnancies from the second through the eighth year, and fewer ectopic pregnancies and removals for pain by the eighth year (Meirik et al., Contraception, August 2009).

Personal comment: This is the long awaited GyneFix effectiveness study. Our clinic has been implanting the GyneFix IUD for the past three years. The implanting procedures have improves significantly since 1993 when the last of the study patients had their GyneFix IUDs implanted. With vastly improved implanting procedures, deeper in the Fundus and with a different anchoring knot, our clinics results bettered this study’s results substantially. For our clinic the expulsions are down to .05 per 100 women and pregnancy rate is .01 per 100 women much better than the ParaGard, TCu380A.

7 comments:

  1. I wonder how this data might help GyneFix's adpotion by the FDA for use in U.S. women.

    ReplyDelete
  2. GyneFix trials are underway in the U.S. working toward FDA approval but it will be several years at the earliest even if the FDA doesn't ask for additional testing.

    ReplyDelete
  3. Where are your clinics? I have been looking for clinics that fit GyneFix and I haven't found any...
    Diana V.

    ReplyDelete
  4. Hi, I just got the GyneFix at a Marie Stopes clinic in Mexico, and I wonder what's the difference between the one with six copper tubes, and the one with 4, I heard the 4 ones is tne mini version, but I'd like to be sure they're the same thing.

    Thanks a lot

    ReplyDelete
  5. Yes, the one with 4 lubes is a GyneFix 200 Vs the 6 tube standard which is a GyneFix 330. The small one is supposed to be as effective as the large one. The difference may be in how long it will remain effective. There should have been a patient leaflet that came with your insertion that gave the manufacturer's suggested replacement date. A link to GyneFix is: http://www.contrel.be/PRODUCTS/gynefix%20info.htm

    ReplyDelete
  6. How can I find a GyneFix provider it the USA? I live in Las Vegas, NV.

    ReplyDelete
  7. Hi, welcome to my world.

    My clinic is participating in a clinical trial which is how my circle got their GyneFix IUDs. The trial has been underway for some time now and no more participants are being accepted. At one time a clinic in the Bay area of California was offering them. I don’t know of anywhere in the U.S. where GyneFix is being offered currently. I think GyneFix is available in Mexico.

    ReplyDelete

Blog Archive

Lijit Search

Labels

Followers

About Me

My photo
Powys , Wales, United Kingdom
I'm a classically trained dancer and SAB grad. A Dance Captain and go-to girl overseeing high-roller entertainment for a major casino/resort