HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant

Launched by UNIVERSITY HOSPITAL, GHENT · Mar 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a gel called HYALOBARRIER® GEL ENDO can help women who have undergone surgery for certain uterine problems—like polyps, fibroids, or adhesions—improve their chances of becoming pregnant and having a baby. The trial will compare the results of women who receive this gel after surgery to those who do not receive it. Researchers will measure how many women in each group achieve a live birth within 30 weeks after being randomly assigned to either group.

To participate in this trial, women must be aged 18 to 47 and scheduled for surgery to remove uterine problems at a fertility clinic in Belgium. They should be hoping to conceive either naturally or with help from fertility treatments. However, women older than 47, those with certain medical conditions or infections, and those who do not wish to conceive after surgery are excluded from the trial. Participants can expect to receive care as part of their routine treatment and will be monitored to see how well the gel works in helping them achieve pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged 18 to 47 years attending Belgian fertility clinics, scheduled for operative hysteroscopy for endometrial polyps, fibroids with uterine cavity deformation, uterine septa, intrauterine adhesions (IUAs) and retained products of conception, and wishing to conceive spontaneously or before fertility treatment with ovulation induction (OI), controlled ovarian stimulation (COS), intrauterine insemination (IUI) or IVF/ICSI.
• Exclusion Criteria:
• • Women younger than 18 years
• • Women 48 years of age or older
• • Women with a known allergy to HYALOBARRIER® GEL ENDO
• • Women with an active infection of the genital tract proven by genital swabs for PCR (Chlamydia, gonococci) or endometrial biopsy (endometritis), not treated at the time of the pre- screening visit. Women adequately treated with proven cure (negative swabs or normal endometrial biopsy) can be included
• • Subserosal fibroids (FIGO or PALM-COEIN classification type 6, 7) - leiomyomas that originate from the myometrium at the serosa of the uterus or intramural fibroids without uterine cavity deformation as documented by ultrasound, hysterography or hysteroscopy - as the sole uterine cavity abnormality identified in the screening phase.
• • Women with fibroids, polyps, uterine septa or IUAs suffering from other symptoms, for instance abnormal uterine bleeding, but not wishing to conceive from 6 weeks following surgery
• • Women with other Müllerian tract anomalies other than a uterine septum as the sole uterine cavity abnormality identified in the screening phase
• • Women who participated in the trial but failed to conceive and who present with a recurrence of polyps, fibroids with cavity deformation, uterine septum or IUAs
• • Women who refuse to give written informed consent.