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PITS: Personalized Insemination Treatment Study

Sponsor
Clinique Ovo (Industry)
Overall Status
Completed
CT.gov ID
NCT03830723
Collaborator
(none)
110
Enrollment
1
Location
1
Arm
20.6
Actual Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Follitropin delta
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
open-label, prospective, dose-finding, single centre pilot study.open-label, prospective, dose-finding, single centre pilot study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination
Actual Study Start Date :
Jan 9, 2020
Actual Primary Completion Date :
Jan 20, 2021
Actual Study Completion Date :
Sep 27, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ovarian response [1 year]

      Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination

    Secondary Outcome Measures

    1. Pregnancy rate [1 year]

      Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Ovo Montréal Quebec Canada H4P 2S4

    Sponsors and Collaborators

    • Clinique Ovo

    Investigators

    • Principal Investigator: Jacques Kadoch, MD, Clinique Ovo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinique Ovo
    ClinicalTrials.gov Identifier:
    NCT03830723
    Other Study ID Numbers:
    • ovord
    First Posted:
    Feb 5, 2019
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Follicle Stimulating Hormone

    Study Results

    No Results Posted as of Jan 11, 2022