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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03830723
Other study ID # ovord
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 9, 2020
Est. completion date September 27, 2021

Study information

Verified date January 2022
Source Clinique Ovo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date September 27, 2021
Est. primary completion date January 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Follitropin delta
Study medication doses during all 3 insemination will be personalized using a suggested algorithm

Locations

Country Name City State
Canada Clinique Ovo Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pregnancy rate Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound 1 year
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