Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on EFI score?

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2014
INTERVENTION: Trade Name: Menopur Pharmaceutical Form: Powder for solution for injection Trade Name: Pregnyl 5000 I.U. Pharmaceutical Form: Powder for solution for injection CONDITION: (Sub)Fertility in endometriosis after laparoscopic removal of the endometriosos lesions: an RCT comparing intra‐uterine insemination with expectant management ; MedDRA version: 16.1 Level: LLT Classification code 10042391 Term: Subfertility System Organ Class: 100000004872 ; MedDRA version: 16.1 Level: LLT Classification code 10014789 Term: Endometriosis, site unspecified System Organ Class: 100000004872 Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: Compare pregnancy rates using two different strategies among women with a recent surgery for endometriosis: comparison of 4 cycles of intra‐uterine insemination (IUI) within 7 menstrual cycles (study group), versus spontaneous evolution during 7 menstrual cycles (control group). Hypothesis: in women receiving IUI the clinical pregnancy rate is significantly higher compared to expectant management. ; ; Primary end point(s): Clinical pregnancy rate is determined in a 3‐step process:; HCG serum measurement at day of ovulation +15; when positive, a second measurement 1 week later ; Transvaginal ultrasound between 3 and 8 weeks after ovulation Secondary Objective: Evaluate the effect of both strategies on time to pregnancy, treatment cost (study group), need for follicle aspiration (study group), multiple pregnancy rate, miscarriage, ectopic pregnancies and delivery rate (live birth rate) Timepoint(s) of evaluation of this end point: HCG serum measurement at day of ovulation +15; when positive, a second measurement 1 week later ; Transvaginal ultrasound between 3 and 8 weeks after ovulation SECONDARY OUTCOME: Secondary end point(s): time to pregnancy, treatment cost (study group), multiple pregnancy rate, miscarriage, ectopic pregnancies and delivery rate (live birth rate) ; need for follicle aspiration (study group), Timepoint(s) of evaluation of this end point: in each IUI treatment cycle: need for follicle aspiration (study group) ; at the end of the study: time to pregnancy, treatment cost (study group), multiple pregnancy rate, miscarriage, ectopic pregnancies and delivery rate (live birth rate) ; INCLUSION CRITERIA: 1. age between 18 and 37 (incl) 2. histologically proven endometriosis with complete resection of all endometriosis lesions during laparoscopy at LUFc 3. EFI score of 7 or more 4. Surgery performed not more than 6 months prior to randomization 5. Regular menstrual cycles (min 24days – max 38days) with proven ovulation 6. At least one functional tube at surgery 7. Sperm sample of partner: normal or mild male factor fresh sample (not frozen/thawed) TMC (total motile sperm count after capacitation) minimally 5 million 8. normal uterine cavity (including arcuate uterus) at hysteroscopy and/or hysterosalpingography and/or gel instillation sonography 9. Postoperative hormone testing: basal FSH below 20 IU/l; AMH measurement needs to be available Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects f
Epistemonikos ID: eea791437b8acfbad3ed84d7dfa4c9903bacba35
First added on: Aug 22, 2024