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Controlled Ovarian StimulationDELTANCT04503707

Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice

An observational study of Controlled Ovarian Stimulation, run by Ferring Pharmaceuticals at 14 sites in France.

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 aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Controlled Ovarian Stimulation
What is being tested?
Follitropin Delta
Type of treatment
Injection or infusion
How many people
250 participants
Where
14 sitesFrance
Study dates
17 Jun 2020to 31 Oct 2021
Phase
Observational
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 years and older
  • Women only
  • Adult, Older adult

Study population: Women who are prescribed REKOVELLE within the approved indication for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment will be invited to participate in the study. Subjects will be enrolled only after the treatment decision has been made and no aspect of this study will interfere with or influence the routine medical procedures and/or medications received.

Who may be able to join

  • Females aged 18 years or older at enrolment
  • Who are treated for IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor
  • Who are prescribed REKOVELLE for the first time and using the dosing algorithm to define the dose regimen: a previous cycle with REKOVELLE should not be allowed
  • Who have been informed verbally and in writing about this study content and who do not object to their data being electronically processed.

Who cannot join

  • Participating in an interventional clinical trial in which any treatment or follow-up is mandated
  • Women with a contraindication for prescription of REKOVELLE treatment
  • Oocyte donors
  • Women undergoing ovarian stimulation for fertility preservation
  • Women undergoing their third or fourth attempt of IVF or ICSI for the current parental project.
  • Subject non-affiliated to French Social Security
  • Women placed under judicial protection, guardianship, or supervision

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Hôpital Pellegrin

    Bordeaux

  • Hôpital Femme Mère Enfant

    Bron

  • Hopital Antoine Béclère

    Clamart

  • Centre Hospitalier Intercommunal de Créteil

    Créteil

  • Centre hospitalier de Lille-Hopital de Flandre

    Lille

  • Institut de Médecine de la Reproduction (there may be other sites in this country)

    Marseille

  • CHU Montpellier

    Montpellier

  • CHU Nantes Hôpital Hôtel Dieu

    Nantes

  • Maternité Port Royal

    Paris

  • Centre Hospitalier Intercommunal de Poissy

    Poissy

  • Clinique Mutualiste La Sagesse

    Rennes

  • Pierre OGER

    Rueil-Malmaison

  • CMCO

    Strasbourg

  • CHU Toulouse - Hôpital Paule de Viguier

    Toulouse

Other trials in France

About this study

Official title: French Prospective Multicentre Non-Interventional Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice

The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.

Being tested
Follitropin Delta
Keywords
Follicle Stimulating Hormone (FSH), Assisted Reproductive Technologies (ART), Follitropin Delta, REKOVELLE

What participants receive

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

  • Follitropin DeltaDrug

    Also called REKOVELLE

    The Intervention (solution for injection) is delivered with a pre-filled injection pen. The REKOVELLE dose will be based on a recent determination (within the last 12 months) of AMH (anti- müllerian hormone) measured by the ELECSYS AMH Plus Immunoassay.

Study groups in NCT04503707
Study groupRoleWhat they receive
Follitropin DeltaTreatment according to routine clinical practice.
Receives: Drug: Follitropin Delta

What is being measured

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

  1. Daily dose of REKOVELLE administered (for naïve and non-naïve subjects)

    Measured: At the end of the stimulation protocol (up to 30 days)

  2. Duration of treatment with REKOVELLE (for naïve and non-naïve subjects)

    Measured: From first until last day of REKOVELLE treatment (up to 30 days)

  3. Use of the dosing App (for naïve and non-naïve subjects)

    Measured: At visit when the daily dose of REKOVELLE is decided (up to 2 hours)

  4. Type of Gonadotropin-Releasing Hormone (GnRH) used (for naïve and non-naïve subjects)

    Measured: At visit (up to 2 hours) during the REKOVELLE treatment period

  5. Duration of treatment with GnRH (for naïve and non-naïve subjects)

    Measured: At the end of the ovarian controlled stimulation (up to 2 weeks)

  6. Treatment used for the triggering of follicle maturation (for naïve and non-naïve subjects)

    Measured: At the last visit during the REKOVELLE treatment period (from 5 to 30 days)

  7. Treatment used for Luteal phase support (for naïve and non-naïve subjects)

    Decided as a choice between Progesterone, Oestrogen and hCG

    Measured: From start of REKOVELLE treatment until 10-11 weeks after embryo transfer

Secondary outcomes (28)

  1. Rate of Ongoing Pregnancy (for naïve and non-naïve subjects)

    Ongoing pregnancy is defined as at least one intrauterine viable fetus, 10-11 weeks after first fresh or frozen embryo/blastocyst transfer.

    Measured: Up to 10-11 weeks after transfer

  2. Number of oocytes retrieved (for naïve and non-naïve subjects)

    Measured: At visit (up to 2 hours) at 36 hours after completed REKOVELLE treatment

  3. Number of oocytes/embryos/blastocysts frozen (for naïve and non-naïve subjects)

    Measured: At Day 3 after oocyte retrieval

  4. Quality of fresh or frozen embryos or blastocysts transferred (excellent, good, fair, other) (for naïve and non-naïve subjects)

    Measured: At Day 3, 5 or 6 after oocyte retrieval

  5. Implantation rate (for naïve and non-naïve subjects)

    Implantation rate is defined as number of intrauterine viable fetus after transfer divided by the number of embryos/blastocysts transferred.

    Measured: Up to 10-11 weeks after transfer

  6. Positive human chorionic gonadotropin (hCG) test (for naïve and non-naïve subjects)

    Proportion of subjects with positive hCG test.

    Measured: Up to 10-11 weeks after transfer

  7. Clinical pregnancy rate (for naïve and non-naïve subjects)

    Clinical pregnancy is defined as least one gestational sac.

    Measured: Up to 5-6 weeks after transfer

  8. Incidence of biochemical pregnancy (for naïve and non-naïve subjects)

    Biochemical pregnancy is defined as positive beta hCG (βhCG) test but no gestational sac is observed on later transvaginal ultrasound, or menstruation is reported.

    Measured: Up to 10-11 weeks after transfer

  9. Incidence of spontaneous abortion (for naïve and non-naïve subjects)

    Spontaneous abortion is defined as positive βhCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there are no viable fetuses observed by ultrasound.

    Measured: Up to 10-11 weeks after transfer

  10. Incidence of elective abortion (for naïve and non-naïve subjects)

    Elective abortion is defined as induced abortion done at the request of the woman for other than therapeutic reasons.

    Measured: Up to 10-11 weeks after transfer

  11. Incidence of vanishing twins (for naïve and non-naïve subjects)

    Vanishing twin is defined as spontaneous disappearance of an intrauterine gestational sac with or without heart beat in a pregnancy where one viable fetus remains as documented by ultrasound.

    Measured: Up to 10-11 weeks after transfer

  12. Incidence of ectopic pregnancy (for naïve and non-naïve subjects)

    Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.

    Measured: Up to 10-11 weeks after transfer

  13. Proportion of subjects with cycle cancellation (for naïve and non-naïve subjects)

    Cancellation could be done before oocyte pick up (due to poor ovarian response, excessive ovarian response, any illness which prevents oocyte collection procedure, subject not taking hCG injection at the correct time, subject choice, other) or after oocyte pick up (due to no oocytes collected, no oocytes fertilized, abnormal fertilization, abnormal embryo development, no embryo development, ovarian hyperstimulation syndrome (OHSS), subject choice, other)

    Measured: Up to 10-11 weeks after transfer

  14. Type of gonadotropin used (previous cycle information for non-naïve subjects)

    Measured: At baseline

  15. Dose of gonadotropin used (previous cycle information for non-naïve subjects)

    Measured: At baseline

  16. Duration of treatment with gonadotropin (previous cycle information for non-naïve subjects)

    Measured: At baseline

  17. Type of GnRH used (previous cycle information for non-naïve subjects)

    Defined as a choice between GnRH agonist and GnRH antagonist

    Measured: At baseline

  18. Duration of treatment with GnRH (previous cycle information for non-naïve subjects)

    Measured: At baseline

  19. Treatment used for the triggering of follicle maturation (previous cycle information for non-naïve subjects)

    Measured: At baseline

  20. Treatment used for Luteal phase support (previous cycle information for non-naïve subjects)

    Decided as a choice between Progesterone, Oestrogen and hCG

    Measured: At baseline

  21. Number of oocytes retrieved (previous cycle information for non-naïve subjects)

    Measured: At baseline

  22. Number of embryos/blastocysts transferred (previous cycle information for non-naïve subjects)

    Measured: At baseline

  23. Incidence of pregnancy loss in women with embryo/blastocyst transfer (previous cycle information for non-naïve subjects)

    Pregnancy loss included biochemical pregnancy, spontaneous / elective abortion, ectopic pregnancy.

    Measured: At baseline

  24. Proportion of subjects with OHSS including moderate/severe grade (previous cycle information for non-naïve subjects)

    Each OHSS case will be classified as moderate or severe.

    Measured: At baseline

  25. Proportion of subjects with preventive interventions for early OHSS (previous cycle information for non-naïve subjects)

    Preventive interventions cover triggering of final follicular maturation with GnRH agonist and fresh embryo/blastocyst transfer or cryopreservation of oocytes/embryos/blastocysts, cycle cancellation, coasting.

    Measured: At baseline

  26. Proportion of subjects with preventive interventions for early OHSS (for naïve and non-naïve subjects)

    Preventive interventions cover triggering of final follicular maturation with GnRH agonist and fresh embryo/blastocyst transfer or cryopreservation of oocytes/embryos/blastocysts, Cycle cancellation, Coasting.

    Measured: Up to 10-11 weeks after transfer

  27. Frequency of adverse drug reactions (ADR) (for naïve and non-naïve subjects)

    An ADR is characterized by the causal relationship between REKOVELLE and the adverse event is at least a reasonable possibility.

    Measured: From start of REKOVELLE treatment until 10-11 weeks after embryo transfer

  28. Monitoring of the REKOVELLE treatment (number and intents of each visit) (for naïve and non-naïve subjects)

    Measured: From Day 1 up to the last day of REKOVELLE stimulation

Timeline

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

  1. First posted7 Aug 2020
  2. Study start17 Jun 2020
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04503707
Sponsor's protocol ID
000370
Acronym
DELTA
Status last verified
Nov 2021
First submitted
26 Jun 2020
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Controlled Ovarian Stimulation, run by Ferring Pharmaceuticals at 14 sites in France.

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 4 inclusion and 7 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 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. 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.

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?

Daily dose of REKOVELLE administered (for naïve and non-naïve subjects) (time frame: At the end of the stimulation protocol (up to 30 days)). The study lists 7 primary outcomes in all. 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 NCT04503707.

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 14 Dec 2021.

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