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InfertilityPhase 4NCT03208972

Elonva in Combination With Hp-FSH Versus Elonva With Low Dose hCG

A Phase 4 study testing low dose hCG, hp-FSH and Corifollitropin Alfa in people with Infertility, run by AZ Jan Palfijn Gent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study compares in a randomized controlled way two stimulation methods. One of these stimulation methods implements a new insight in ovarian follicular growth. If this novel method of stimulation proves to be as efficient as the classical stimulation protocols, there might be a dramatic reduction of the costs of… Read more about this study

Who is it for?
Ages 18 to 38 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
low dose hCG, hp-FSH and Corifollitropin Alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteBelgium
Study dates
Oct 2014to Nov 2015
Phase
Phase 4
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 38 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • IVF/ICSI patients
  • Cycle 1, 2, 3, 4

Who cannot join

  • PCOS
  • Endocrinological diseases

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • AZ Jan Palfijn

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

About this study

Official title: Prospective Randomized Trial Comparing Ovarian Stimulation in IVF-patients With Corifollitropin Alfa in Combination With Hp-FSH Versus Corifollitropin Alfa in Combination With Low Dose hCG

The study compares in a randomized controlled way two stimulation methods. One of these stimulation methods implements a new insight in ovarian follicular growth. If this novel method of stimulation proves to be as efficient as the classical stimulation protocols, there might be a dramatic reduction of the costs of the medical therapy in IVF, thus reducing also the overall IVf costs significantly.

Conditions
Infertility
Being tested
low dose hCG, hp-FSH, Corifollitropin Alfa
Keywords
IVF, ovarian stimulation, low dose hCG, hp-FSH, Corifollitropin Alfa, costs of IVF
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low dose hCGDrug

    Also called Pregnyl

  • hp-FSHDrug

    Also called Menopur

  • Corifollitropin AlfaDrug

    Also called Elonva

    Corifollitropin Alfa (Elonva) dosage depending on weight, once administered first day of ovarian stimulation for all subjects, and on day 7 they proceed with the treatment of the allocated group.

    <60 kg: Elonva 100 MCG > 60 kg: Elonva 150 MCG

Study groups in NCT03208972
Study groupRoleWhat they receive
low dose hCG (Pregnyl)ExperimentalCorifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination 150IU low dose hCG from day 7 until final oocyte maturation.
Receives: Drug: low dose hCG; Drug: Corifollitropin Alfa
hp-FSH (Menopur)Active comparatorCorifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination with hp-FSH until final oocyte maturation.
Receives: Drug: hp-FSH; Drug: Corifollitropin Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The financial costs of the stimulation in both groups

    Measured: 1 year

Secondary outcomes (5)

  1. The number of MII oocytes obtained at the occasion of the oocyte retrieval

    Measured: 3 weeks

  2. pregnancy rate

    Measured: 5 weeks

  3. duration of the stimulation

    Measured: one month

  4. hormonal levels reached at time of induction of final maturation of the oocyte

    Measured: 3 weeks

  5. the number of clinical OHSS patients

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2017
  2. Study startOct 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03208972
Sponsor's protocol ID
2012-005676-34
Status last verified
Feb 2021
First submitted
7 May 2014
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing low dose hCG, hp-FSH and Corifollitropin Alfa in people with Infertility, run by AZ Jan Palfijn Gent at 1 site in Belgium.

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 2 inclusion and 2 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 3 Feb 2021. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

The financial costs of the stimulation in both groups (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03208972.

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 3 Feb 2021.

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