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Completed

NCT Number: NCT04503707

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.

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Key information

Conditions

Controlled Ovarian Stimulation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Pellegrin, Bordeaux, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Follitropin delta

Drug

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.

Other names: REKOVELLE

Primary outcomes

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

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

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

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

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

    Time frame: 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)

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

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

    Time frame: 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)

    Time frame: 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)

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

    Decided as a choice between Progesterone, Oestrogen and hCG

Secondary outcomes

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

    Time frame: Up to 10-11 weeks after transfer

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

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

    Time frame: 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)

    Time frame: 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)

    Time frame: At Day 3, 5 or 6 after oocyte retrieval

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

    Time frame: Up to 10-11 weeks after transfer

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

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

    Time frame: Up to 10-11 weeks after transfer

    Proportion of subjects with positive hCG test.

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

    Time frame: Up to 5-6 weeks after transfer

    Clinical pregnancy is defined as least one gestational sac.

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

    Time frame: Up to 10-11 weeks after transfer

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

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

    Time frame: Up to 10-11 weeks after transfer

    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.

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

    Time frame: Up to 10-11 weeks after transfer

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

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

    Time frame: Up to 10-11 weeks after transfer

    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.

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

    Time frame: Up to 10-11 weeks after transfer

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

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

    Time frame: Up to 10-11 weeks after transfer

    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)

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

    Time frame: At baseline

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

    Time frame: At baseline

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

    Time frame: At baseline

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

    Time frame: At baseline

    Defined as a choice between GnRH agonist and GnRH antagonist

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

    Time frame: At baseline

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

    Time frame: At baseline

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

    Time frame: At baseline

    Decided as a choice between Progesterone, Oestrogen and hCG

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

    Time frame: At baseline

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

    Time frame: At baseline

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

    Time frame: At baseline

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

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

    Time frame: At baseline

    Each OHSS case will be classified as moderate or severe.

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

    Time frame: At baseline

    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.

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

    Time frame: Up to 10-11 weeks after transfer

    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.

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: DELTA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2020
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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