Personalized Insemination Treatment Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination

Conditions
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Infertility, Intrauterine Insemination, Reproduction

Intervention / Treatment
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* Drug: Follitropin delta


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open-label, prospective, dose-finding, single centre pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rekovelle (Follitropin delta)<br>All participants will receive a prescription for study medication Rekovelle (follitropin delta) | Drug: Follitropin delta<br>* Study medication doses during all 3 insemination will be personalized using a suggested algorithm<br>* Other names: Rekovelle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound | 1 year |