(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
Conditions
Interventions
Trade Name: Menopur
Pharmaceutical Form: Powder for solution for injection
Trade Name: Pregnyl 5000 I.U.
Pharmaceutical Form: Powder for solution for injection
Sponsors
University Hospital Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
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 for this age range 94 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - frozen (donor or partner) sperm - clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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);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;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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Belgium
Contacts
Public ContactFertility Center
University Hospital Leuven
Outcome results
None listed