Subfertility MedDRA version: 12.1 Level: LLT Classification code 10042391 Term: Subfertility MedDRA version: 12.1 Level: LLT Classification code 10042392 Term: Subfertility (female)
Conditions
Interventions
Trade Name: Crinone 8% Progesterone Vaginal Gel
Pharmaceutical Form: Vaginal gel
Sponsors
University Hospital Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women: Normo-ovulatory ( cycles: 26-32d), age=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with a contra indication for the use of crinone : Known hypersensitivity to progesterone or one of the components of Crinone, vaginal bleeding of unknown origin, known or suspected malignancy of the breast or the reproductive system, acute porphyria, meningioma, patients with a history of or experiencing thrombophlebitis, trombo-embolic disease or cerebrovascular accident, non-ongoing pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate when compared to no luteal phase support in a program of intrauterine insemination after controlled ovarian stimulation with gonadotrophins;Secondary Objective: Test the hypothesis that luteal phase support with vaginal progesterone leads to a higher live birth rate when compared to no luteal phase support in a program of intrauterine insemination after controlled ovarian stimulation with gonadotrophins;Primary end point(s): Clinical pregnancy rate per IUI cycle: positive ultrasound with gestational sac and at least one fetal heart beat detected by ultrasound at ± 5 to 6 weeks after IUI | — |
Countries
Belgium
Outcome results
None listed