Personalized Insemination Treatment Study

NCT ID: NCT03830723

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2021-09-27

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

Conditions

Infertility; Intrauterine Insemination; Reproduction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rekovelle (Follitropin delta)

All participants will receive a prescription for study medication Rekovelle (follitropin delta)

Group Type: OTHER

Follitropin delta

Intervention Type: DRUG

Study medication doses during all 3 insemination will be personalized using a suggested algorithm

Interventions

Follitropin delta

Study medication doses during all 3 insemination will be personalized using a suggested algorithm

Intervention Type: DRUG

Other Intervention Names

Rekovelle

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinique Ovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Kadoch, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

Clinique Ovo

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

ovord

Identifier Type: -

Identifier Source: org_study_id