Immediate Intra Uterine Isemination (IUI) Versus Expectant Management in Postoperative Endometriosis Patients
Not Applicable
Terminated
- Conditions
- EndometriosisInfertility
- Interventions
- Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination
- Registration Number
- NCT02636400
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on their EFI score? (A single centre randomised controlled trial).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
- recent (<6months) complete laparoscopic endometriosis resection
- endometriosis fertility index (EFI) at least 7/10
- Regular menstrual cycles (min 24days - max 38days) with proven ovulation
- At least one functional tube at surgery, normal uterus
- Sperm sample of partner: normal or mild male factor
Exclusion Criteria
- frozen (donor or partner) sperm
- clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
- FSH > 20 IU/L
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description postop IUI controlled ovarian stimulation with gonadotropins + intrauterine insemination 4 IUI cycles within 7 menstrual cycles
- Primary Outcome Measures
Name Time Method cumulative clinical pregnancy rate participants will be followed for the duration of 7 menstrual cycles and in case of pregnancy, they will be followed until the pregnancy outcome is known, implying an average time frame of 1.5 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium