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Personalized Insemination Treatment Study (PITS)

Primary Purpose

Infertility, Intrauterine Insemination, Reproduction

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Follitropin delta
Sponsored by
Clinique Ovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Clinique Ovo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Rekovelle (Follitropin delta)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pregnancy rate
Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound

Full Information

First Posted
January 30, 2019
Last Updated
September 8, 2022
Sponsor
Clinique Ovo
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1. Study Identification

Unique Protocol Identification Number
NCT03830723
Brief Title
Personalized Insemination Treatment Study
Acronym
PITS
Official Title
Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Ovo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Intrauterine Insemination, Reproduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open-label, prospective, dose-finding, single centre pilot study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rekovelle (Follitropin delta)
Arm Type
Other
Arm Description
All participants will receive a prescription for study medication Rekovelle (follitropin delta)
Intervention Type
Drug
Intervention Name(s)
Follitropin delta
Other Intervention Name(s)
Rekovelle
Intervention Description
Study medication doses during all 3 insemination will be personalized using a suggested algorithm
Primary Outcome Measure Information:
Title
Ovarian response
Description
Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Fertile women undergoing intrauterine insemination
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Kadoch, MD
Organizational Affiliation
Clinique Ovo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Ovo
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4P 2S4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Personalized Insemination Treatment Study

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