Personalized Insemination Treatment Study

Phase 2

Completed

• Conditions: Infertility; Reproduction; Intrauterine Insemination
• Interventions: Drug: Follitropin delta

• Registration Number: NCT03830723
• Lead Sponsor: Clinique Ovo

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

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2020-01-09
• Primary Completion: 2021-01-20
• Study Completion: 2021-09-27
• Status Verified: 2022-01
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rekovelle (Follitropin delta)	Follitropin delta	All participants will receive a prescription for study medication Rekovelle (follitropin delta)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pregnancy rate	1 year	Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montréal, Quebec, Canada