Personalized Insemination Treatment Study

NCT03830723 | Completed Phase 2

• 1 other identifier: ovord
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Intrauterine Insemination; Reproduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pregnancy rate

  1 year

Study Arms (1)

Rekovelle (Follitropin delta)

OTHER

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

Drug: Follitropin delta

Interventions

Follitropin delta DRUG

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

Also known as: Rekovelle

Rekovelle (Follitropin delta)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Fertile women undergoing intrauterine insemination
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin delta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jacques Kadoch, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, prospective, dose-finding, single centre pilot study.

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 5, 2019
• Study Start: January 9, 2020
• Primary Completion: January 20, 2021
• Study Completion: September 27, 2021
• Last Updated: September 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)