InfertilityPhase 2PITSNCT03830723
Personalized Insemination Treatment Study
A Phase 2 study testing Follitropin delta in people with Infertility and Intrauterine Insemination, run by Clinique Ovo at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Intrauterine Insemination, Reproduction
- What is being tested?
- Follitropin delta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2020to 27 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination
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.
Read the 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
- Conditions
- Infertility, Intrauterine Insemination, Reproduction
- Being tested
- Follitropin delta
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin deltaDrug
Also called Rekovelle
Study medication doses during all 3 insemination will be personalized using a suggested algorithm
| Study group | Role | What they receive |
|---|---|---|
| Rekovelle (Follitropin delta) | Other | All participants will receive a prescription for study medication Rekovelle (follitropin delta) Receives: Drug: Follitropin delta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian response
Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination
Measured: 1 year
Secondary outcomes (1)
Pregnancy rate
Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start9 Jan 2020
- Primary completion20 Jan 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, prospective, dose-finding, single centre pilot study.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830723
- Sponsor's protocol ID
- ovord
- Acronym
- PITS
- Status last verified
- Jan 2022
- First submitted
- 30 Jan 2019
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination
- ClinicalTrials.gov ID
- NCT03830723
- Acronym / sponsor ID
- PITS / ovord
- Conditions
- Infertility, Intrauterine Insemination, Reproduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, prospective, dose-finding, single centre pilot study.
| Arm | Type | Receives |
|---|---|---|
| Rekovelle (Follitropin delta) | Other | Drug: Follitropin deltaAll participants will receive a prescription for study medication Rekovelle (follitropin delta) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follitropin deltaAlso: RekovelleStudy medication doses during all 3 insemination will be personalized using a suggested algorithm | Drug | Rekovelle (Follitropin delta) |
Primary outcome
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
1 secondary outcome
Pregnancy rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Kadoch, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Follitropin delta in people with Infertility and Intrauterine Insemination, run by Clinique Ovo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.