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InfertilityPhase 2TIFFANYNCT05571111

Clinical Research Study to Learn About the Effect and Safety of Different Doses of FE 999302 When Given as a Single Dose for Final Development of the Eggs After Ovarian Stimulation

A Phase 2 study testing FE 999302, Ovitrelle and Novarel in people with Infertility, run by Ferring Pharmaceuticals at 3 sites in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary purpose of this trial is to compare three different doses of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL on oocyte maturity when administered as a single dose for final development of the oocytes in women undergoing controlled ovarian stimulation. Read more about this study

Who is it for?
Ages 18 to 42 years, women only
Conditions the study is for
Infertility
What is being tested?
FE 999302, Ovitrelle and Novarel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesSpain
Study dates
4 Oct 2022to 25 Jun 2024
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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pre-menopausal women between the ages of 18 and 42 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent.
  • Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
  • Infertility for at least 1 year before screening for subjects <35 years or for at least 6 months for subjects ≥35 years (not applicable in case of tubal or severe male factor infertility).
  • No more than two controlled ovarian stimulation cycles initiated, regardless outcome (taking exclusion criteria 3, 4, and 5 into account).
  • Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.

Who cannot join

  • Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
  • Considered unsuitable for controlled ovarian stimulation with a starting dose of 150 or 225 IU/day highly purified human menopausal gonadotropin (HP-hMG), as judged by the investigator.
  • Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day or higher. Poor response is defined as <4 oocytes retrieved, or cycle cancellation prior to oocyte retrieval due to inadequate follicular development.
  • Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/hMG dose of ≤225 IU, defined as ≥25 oocytes retrieved or cycle cancellation prior to oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
  • Severe OHSS in a previous controlled ovarian stimulation cycle.

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Ferring Investigational Site

    Madrid, 28023

  • Ferring Investigational Site

    Seville, 41092

  • Ferring Investigational Site

    Valencia, 46015

Other trials in Spain

About this study

Official title: A Randomised, Assessor-blind, Active-controlled, Parallel-group, Dose-finding Trial to Investigate the Efficacy and Safety of FE 999302 for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation

The primary purpose of this trial is to compare three different doses of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL on oocyte maturity when administered as a single dose for final development of the oocytes in women undergoing controlled ovarian stimulation.

Conditions
Infertility
Being tested
FE 999302, Ovitrelle, Novarel
Medical subject headings
Infertility

What participants receive

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

  • FE 999302Drug

    Also called recombinant hCG

    Subcutaneous injection as a single dose. 3 different doses

  • OvitrelleDrug

    Subcutaneous injection as a single dose. 250 µg (0.5 mL)

  • NovarelDrug

    Subcutaneous injection as a single dose. 10,000 IU (1 mL)

Study groups in NCT05571111
Study groupRoleWhat they receive
Dose 1 of FE 999302ExperimentalSubcutaneous injection of Dose 1 of FE 999302 as a single dose.
Receives: Drug: FE 999302
Dose 2 of FE 999302ExperimentalSubcutaneous injection of Dose 2 of FE 999302 as a single dose.
Receives: Drug: FE 999302
Dose 3 of FE 999302ExperimentalSubcutaneous injection of Dose 3 of FE 999302 as a single dose.
Receives: Drug: FE 999302
250 μg OVITRELLEActive comparatorSubcutaneous injection of 250 μg of OVITRELLE. 0.5 mL as a single dose.
Receives: Drug: Ovitrelle
10,000 IU NOVARELActive comparatorSubcutaneous injection of 10,000 IU NOVAREL. 1 mL as a single dose.
Receives: Drug: Novarel

What is being measured

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

  1. Number of metaphase II (MII) oocytes

    Measured: On the day of oocyte retrieval (2 days after triggering)

Secondary outcomes (22)

  1. Number of oocytes retrieved

    Measured: On the day of oocyte retrieval (2 days after triggering)

  2. Number of fertilised (2 pronuclei) oocytes

    Measured: On day 1 insemination (3 days after triggering)

  3. Number and quality of embryos on day 3 after oocyte retrieval

    Measured: Day 3 after insemination (5 days after triggering)

  4. Number and quality of blastocysts on day 5 after oocyte retrieval

    Measured: Day 5 after insemination (7 days after triggering)

  5. Serum hormone concentrations of progesterone

    Measured: Blood samples for analysis of circulating concentrations of progesterone will be drawn at several visits from day of triggering up to 22 days after triggering

  6. Serum hormone concentrations of 17-OH-progesterone

    Measured: Blood samples for analysis of circulating concentrations of 17-OH-progesterone will be drawn at several visits from day of triggering up to 22 days after triggering

  7. Serum hormone concentrations of estradiol

    Measured: Blood samples for analysis of circulating concentrations of estradiol will be drawn at several visits from day of triggering up to 22 days after triggering

  8. Serum hormone concentrations of follicle stimulating hormone (FSH)

    Measured: Blood samples for analysis of circulating concentrations of follicle stimulating hormone (FSH) will be drawn at several visits from day of triggering up to 22 days after triggering

  9. Serum hormone concentrations of luteinising hormone (LH)

    Measured: Blood samples for analysis of circulating concentrations of luteinising hormone (LH) will be drawn at several visits from day of triggering up to 22 days after triggering

  10. Positive βhCG (positive serum βhCG test 13-15 days after transfer)

    Measured: 20-22 days after triggering

  11. Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer)

    Measured: 6-7 weeks after triggering

  12. Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)

    Measured: 6-7 weeks after triggering

  13. Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)

    Measured: 11-12 weeks after triggering

  14. Serum hCG concentrations at end-of-stimulation, the day after triggering, at oocyte retrieval, on day 5 after oocyte retrieval (transfer), and on day 7-9 after oocyte retrieval (mid luteal phase)

    Measured: Blood samples for analysis of circulating concentrations of hCG will be drawn at several visits from day of triggering up to 9-11 days after triggering

  15. Ovarian hyperstimulation syndrome (OHSS), overall and by timing, grade, and severity

    Early OHSS is defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Late OHSS is defined as OHSS with onset >9 days after triggering of final follicular maturation.

    Measured: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS)

  16. Injection site reactions (redness, pain, itching, swelling, and bruising) assessed by the subject following administration of investigational medicinal product (IMP)

    Measured: Immediately, 30 minutes, and 24 hours after injection

  17. Treatment-induced anti-hCG antibodies, overall as well as with neutralising capacity

    Measured: Day of triggering up until 19-28 days after triggering

  18. Multi-fetal gestation

    Measured: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)

  19. Biochemical pregnancy

    Measured: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)

  20. Spontaneous abortion

    Measured: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)

  21. Ectopic pregnancy (with and without medical/surgical intervention)

    Measured: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)

  22. Vanishing twins

    Measured: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)

Timeline

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

  1. First posted7 Oct 2022
  2. Study start4 Oct 2022
  3. Primary completion25 Mar 2024 (estimated)
  4. Study completion25 Jun 2024 (estimated)

Why it stopped: Based on company decision to close the project. No trial participants received any study drug.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05571111
Sponsor's protocol ID
000298
Acronym
TIFFANY
Status last verified
Jul 2022
First submitted
28 Sep 2022
Last updated
9 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FE 999302, Ovitrelle and Novarel in people with Infertility, run by Ferring Pharmaceuticals at 3 sites in Spain.

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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. 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 was withdrawn before enrolling participants, so there are no results.

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?

Number of metaphase II (MII) oocytes (time frame: On the day of oocyte retrieval (2 days after triggering)). 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 NCT05571111.

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 9 Jan 2023.

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