Status:
COMPLETED
Personalized Insemination Treatment Study
Lead Sponsor:
Clinique Ovo
Conditions:
Infertility
Intrauterine Insemination
Eligibility:
FEMALE
18-42 years
Phase:
PHASE2
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 insemina...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03830723
Start Date
January 9 2020
End Date
September 27 2021
Last Update
September 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinique Ovo
Montreal, Quebec, Canada, H4P 2S4