Personalized Insemination Treatment Study (PITS)

Ovo Clinic

Status and phase: Completed; Phase 2

Conditions: Intrauterine Insemination; Infertility; Reproduction

Treatments: Drug: Follitropin delta

Study type: Interventional

Funder types: Industry

Identifiers

NCT03830723

ovord

Details and patient eligibility

About

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.

Full 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

Enrollment: 110 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Rekovelle (Follitropin delta)

Other group

Description:

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

Treatment:

Drug: Follitropin delta