Infertility Clinical Trial
— PITSOfficial title:
Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination
Verified date | January 2022 |
Source | Clinique Ovo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | September 27, 2021 |
Est. primary completion date | January 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Clinique Ovo | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Clinique Ovo |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ovarian response | Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination | 1 year | |
Secondary | Pregnancy rate | Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound | 1 year |
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