Personalized Insemination Treatment Study

Infertility Clinical Trial

— PITS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830723
• Other study ID #: ovord
• Status: Completed
• Phase: Phase 2
• Start date: January 9, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: January 2022
• Source: Clinique Ovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 27, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• Intrauterine Insemination
• Reproduction

Intervention

Drug:
• Follitropin delta
Study medication doses during all 3 insemination will be personalized using a suggested algorithm

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pregnancy rate	Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound	1 year