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NCT00702845·Phase 3·INTERVENTIONAL

To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)

GanirelixOtherCompleted

Status

Completed

Phase

Phase 3

Enrollment

397

Locations

0

Results

Posted

Publications

3

Study summary

What the protocol is testing.

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.

Full detailed description

This is a randomized, double-blind, active-controlled, equivalence clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in COS for Assisted Reproductive Technology (ART). For this regimen, patients receive a single injection of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group patients receive daily injections of recFSH up to the day of triggering final oocyte maturation. Equivalence between the two treatment groups in the number of oocytes retrieved is the primary objective of this trial.

Interventions

Treatment arms and agents.

DRUG

corifollitropin alfa (Org 36286)

100 µg corifollitropin alfa subcutaneous (SC) injection

DRUG

recFSH (follitropin beta)

150 IU recFSH SC injection

DRUG

gonadatropin releasing hormone (GnRH) antagonist (ganirelix)

GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day

DRUG

human chorion gonadatropin (hCG)

hCG 5,000 IU or 10,000 IU administered SC

BIOLOGICAL

progesterone

Progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.

DRUG

placebo-recFSH (follitropin alfa)

Placebo-recFSH administered at the equivalent volume of 150 IU/day.

DRUG

placebo-corifollitropin alfa

Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle.

BIOLOGICAL

open-label recFSH

Open-label recFSH administered up to a maximum dose of 200 IU/day.

Timeline

From registration to results.

  1. First posted

    Jun 20, 2008

  2. Study start

    Dec 28, 2006

  3. Primary completion

    Jul 7, 2007

  4. Study completion

    Nov 15, 2007

  5. Results posted

    Apr 27, 2015

  6. Registry updated

    Jun 18, 2024

Outcomes

What the study measures.

Primary outcomes

Number of Cumulus-oocyte-complexes Retrieved, Per Attempt

Time frame · One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)

The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.

Secondary outcomes

Total Dose of recFSH Administered

Time frame · One COS cycle (up to a maximum total duration of 19 stimulation days)

Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles \>=17mm).

Total Dose of recFSH Administered From Day 8 Onwards

Time frame · Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)

Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles \>=17mm).

Number of Days Treated With recFSH

Time frame · One COS cycle (up to a maximum total duration of 19 stimulation days)

Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles \>=17mm).

Total Duration of Stimulation (Days)

Time frame · One COS cycle (up to a maximum total duration of 19 stimulation days)

Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.

Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)

Time frame · Predose up to 2 weeks after ET (up to maximum of 6 weeks)

Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)

Time frame · Predose up to 2 weeks after ET (up to maximum of 6 weeks)

Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)

Time frame · Predose up to 2 weeks after ET (up to maximum of 6 weeks)

Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)

Time frame · Predose up to 2 weeks after ET (up to maximum of 6 weeks)

Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)

Time frame · Predose up to 2 weeks after ET (up to maximum of 6 weeks)

Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration

Time frame · Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)

For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
36 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * Females of couples with an indication for COS and IVF or ICSI; * \>=18 and \<= 36 years of age at the time of signing informed consent; * Body weight \<= 60 kg and 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 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/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, 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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

PMID 20483664 ↗Corifollitropin alfa Ensure Study Group. Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women. Reprod Biomed Online. 2010 Jul;21(1):66-76. doi: 10.1016/j.rbmo.2010.03.019. Epub 2010 Mar 28.PMID 26991902 ↗Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.PMID 26950065 ↗Griesinger G, Verweij PJ, Gates D, Devroey P, Gordon K, Stegmann BJ, Tarlatzis BC. Prediction of Ovarian Hyperstimulation Syndrome in Patients Treated with Corifollitropin alfa or rFSH in a GnRH Antagonist Protocol. PLoS One. 2016 Mar 7;11(3):e0149615. doi: 10.1371/journal.pone.0149615. eCollection 2016.

Primary links

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ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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