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Completed

NCT Number: NCT00696800

A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.

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Key information

Conditions

In Vitro Fertilization Genital Diseases Infertility Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

This is a randomized, double-blind, active-controlled, non-inferiority clinical trial investigating the efficacy and safety of a new treatment regimen with Corifollitropin Alfa, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in controlled ovarian stimulation for Assisted Reproductive Technology (ART). For this regimen, participants receive a single injection of Corifollitropin Alfa and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group participants receive daily injections of recFSH up to the day of triggering final oocyte maturation. Non-inferiority in ongoing pregnancy rates (assessed at least 10 weeks after embryo transfer) will be the primary endpoint for this trial. The number of oocytes retrieved will be analyzed as co-primary endpoint.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females of couples with an indication for Controlled Ovarian Stimulation (COS) and in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI);
  • >=18 and <=36 years of age at the time of signing informed consent;
  • Body weight > 60 and <=90 kg and body mass index (BMI) >=18 and <=32 kg/m^2;
  • Normal menstrual cycle length: 24-35 days;
  • Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
  • Willing and able to sign informed consent.

Exclusion criteria

  • History of/or any current (treated) endocrine abnormality;
  • History of ovarian hyper-response or ovarian hyperstimulation syndrome

(OHSS);

  • History of/or current polycystic ovary syndrome (PCOS);
  • More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on ultrasound scan (USS) in the early follicular phase (menstrual cycle day 2-5);
  • Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);
  • Presence of unilateral or bilateral hydrosalphinx (visible on USS);
  • Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >=5 cm;
  • More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable);
  • History of non- or low ovarian response to FSH/ human menopausal gonadotropin (hMG) treatment;
  • History of recurrent miscarriage (3 or more, even when unexplained);
  • FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
  • Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
  • Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
  • Recent history of/or current epilepsy, human immunodeficiency virus (HIV) infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
  • Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
  • Smoking more than 5 cigarettes per day;
  • History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
  • Previous use of Org 36286;
  • Use of hormonal preparations within 1 month prior to randomization;
  • Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
  • Administration of investigational drugs within three months prior to signing informed consent.

Treatment and study plan

Corifollitropin alfa

Drug

On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.

Other names: MK-8962, SCH 900962, Org 36286

RecFSH / Follitropin beta (Days 1 to 7)

Biological

Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

Other names: Puregon / Follistim AQ Cartridge

Placebo Corifollitropin alfa

Drug

Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.

Placebo RecFSH / follitropin beta

Drug

Identical ready-for-use solution, but without the active ingedient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

RecFSH / Follitropin beta (Days 8 to hCG)

Biological

From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

Other names: Puregon / Follistim AQ Cartridge

Ganirelix

Drug

On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG

Other names: Orgalutran/ Ganirelix Acetate Injection

hCG

Biological

When 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP

Other names: Pregnyl / urinary hCG

progesterone

Biological

On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.

Primary outcomes

  1. Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)

    Time frame: Assessed at least 10 weeks after embryo transfer (up to 1 year)

    An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.

  2. Mean Number of Oocytes Retrieved

    Time frame: Up to 36 hours after administration of hCG (up to 1 year)

    Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.

Secondary outcomes

  1. Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1

    Time frame: From Day 1 to day of hCG treatment (up to 1 year)

    The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 1 onwards.

  2. Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8

    Time frame: From Day 8 to Day of hCG treatment (up to 1 year)

    The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 8 onwards.

  3. Serum FSH Levels During Stimulation

    Time frame: Up to day of hCG treatment (up to 1 year)

    Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.

  4. Serum Luteinizing Hormone (LH) Levels During Stimulation

    Time frame: Up to day of hCG treatment (up to 1 year)

    Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.

  5. Serum Estradiol (E2) Levels During Stimulation

    Time frame: Up to day of hCG treatment (up to 1 year)

    Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.

  6. Serum Progesterone (P) Levels During Stimulation

    Time frame: Up to day of hCG treatment (up to 1 year)

    Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment

  7. Serum Inhibin-B Levels During Stimulation

    Time frame: Up to day of hCG treatment (up to 1 year)

    Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment

  8. Number of Follicles Categorized by Size on Stimulation Day 1

    Time frame: On Day 1 of treatment (up to 1 year)

    Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size.

  9. Number of Follicles Categorized by Size on Stimulation Day 5

    Time frame: On Day 5 of treatment (up to 1 year)

    Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.

  10. Number of Follicles Categorized by Size on Stimulation Day 8

    Time frame: On Day 8 of treatment (up to 1 year)

    Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.

  11. Number of Follicles Categorized by Size on the Day of hCG

    Time frame: Day of HCG treatment (up to 1 year)

    Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.

  12. Number of Cumulus-oocyte-complexes

    Time frame: Up to 36 hours after administration of hCG (up to 1 year)

    Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed

  13. Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)

    Time frame: Up to 36 hours after administration of hCG (up to 1 year)

    The number of oocytes used for ICSI was assessed, and categorized based on their quality

  14. Percentage of Fertilized Oocytes (Fertilization Rate)

    Time frame: Up to 18 hours after start of fertilization (up to 1 year)

    The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI

  15. Number of Embryos Obtained on Day 3 Categorized by Quality

    Time frame: Post fertilization Day 3 (up to 1 year)

    Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality.

  16. Number of Embryos Transferred on Day 3

    Time frame: Post fertilization Day 3 (up to 1 year)

    After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account.

  17. Percentage of Gestational Sacs (Implantation Rate)

    Time frame: Up to 6 weeks after embryo transfer (up to 1 year)

    The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred.

  18. Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy

    Time frame: Up to day of miscarriage (up to 1 year)

    The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth.

  19. Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy

    Time frame: Up to day of miscarriage (up to 1 year)

    The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity.

  20. Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt

    Time frame: Two weeks after embryo transfer (up to 1 year)

    Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.

  21. Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer

    Time frame: Two weeks after embryo transfer (up to 1 year)

    Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Active-Controlled, Non-Inferiority Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as Reference

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 13, 2008
Registry last updated
Jun 20, 2024

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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