Personalized Insemination Treatment Study (PITS)

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Intrauterine Insemination; Reproduction
• Intervention / Treatment: Drug: Follitropin delta

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4P 2S4
      • Clinique OVO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Rekovelle (Follitropin delta); All participants will receive a prescription for study medication Rekovelle (follitropin delta)	Drug: Follitropin delta; Study medication doses during all 3 insemination will be personalized using a suggested algorithm; Other Names: Rekovelle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound	1 year

Collaborators and Investigators

• Sponsor: Clinique Ovo

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone
• Other Study ID Numbers: ovord

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No