Personalized Insemination Treatment Study

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Clinique Ovo; OVO R & D
• Treatments: Follicle Stimulating Hormone

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)