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Completed

NCT Number: NCT03830723

Personalized Insemination Treatment Study

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Follitropin delta

Drug

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

Other names: Rekovelle

Primary outcomes

  1. Ovarian response

    Time frame: 1 year

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

Secondary outcomes

  1. Pregnancy rate

    Time frame: 1 year

    Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Registry information

Official study title

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

Acronym: PITS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2019
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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