Infertility, Intrauterine Insemination, Reproduction
Conditions
Brief summary
This study is intended for women undergoing their first cycle of 3 intrauterine inseminations. All 3 inseminations will be personalized by using algorithms to determine the dose of study medication.
Detailed description
Study medication dosage for the first insemination cycle will be based on the woman's age as well as her Anti-Mullerian Hormone (AMH) levels. Study medication dosage for the second and third insemination will depend on ovarian response (number of follicles) during previous insemination cycle and woman's age
Interventions
Study medication doses during all 3 insemination will be personalized using a suggested algorithm
Sponsors
Clinique Ovo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label, prospective, dose-finding, single centre pilot study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* Women having consented to the study * Women followed at fertility center * First IUI cycle * Women between the ages of 18 to 42 inclusively at time of consent form signature * AMH \< 35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months * At least one permeable Fallopian tube confirmed by laparoscopy, hysterosalpingography (HSG), hysterosalpingosonography (HSSG) or one pregnancy in the last 3 years * Insemination with either partner or donor sperm * Male partner semen analysis considered adequate for IUI in accordance to the centre's standard practice * Menstrual cycles from 26 to 39 days * Presence of both ovaries
Exclusion criteria
* Unable to consent * Body weight \>100 kg * AMH ≥35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months * Severe malformation (unicornuate or bicornuate uterus) or uterine anomaly including fibroids ≥ 5 cm * Uncontrolled thyroid or adrenal dysfunction * Pituitary tumour * Persistent ovarian cysts or enlargement not due to PCOS (Polycystic ovary syndrome) \> 3 cm * Anovulatory women * Use of contraceptives in the last 3 months prior to start of stimulation * Diagnosis of hydrosalpinx * Malignancies * Breast pathology incompatible with gonadotropin stimulation * Hypersensitivity to follitropin delta or to any ingredient in the formulation * Addition of other infertility medication that can influence follicle stimulation and maturation such as growth hormone (GH)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian response | 1 year | Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | 1 year | Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound |
Countries
Canada
Outcome results
None listed