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Trial · Interventional

TerminatedPhase 3Results postedRegistry data

Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle

Short name Luveris in ART

NCTNCT01071200 (opens ClinicalTrials.gov in a new tab)Other idIMP25289Other id2004-002218-13Other id2004
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names hCG (human chorionic gonadotropin), does not test it. It appears in the description.

Overview

Status
Terminated
Phase
Phase 3
Enrollment
133 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Italy

Start
Mar 2005
Primary completion
Apr 2009
Completion
Apr 2009
First posted
19 Feb 2010 (estimated)
Last update posted
27 Dec 2013 (estimated)
Conditions
Reproductive Techniques, Assisted

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007200820092010
  1. Ph 3

    Luveris in ART

    NCT01071200

    Mar 2005 to Apr 2009

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) \>3500 International Unit (IU), the possibility to decrease through recombinant human luteinizing hormone (r-hLH) supplementation, the FSH amount per oocytes retrieved and in the mean time to improve the overall cycle outcome.

Interventions

  • Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH)Drug
  • r-hFSHDrug

Arms2

  • Experimental

    A

    Subjects treated with r-hFSH and r-hLH (2:1 ratio of r-hFSH:r-hLH)

  • Active comparator

    B

    Subjects treated with r-hFSH alone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes

    Time frame · Baseline (Stimulation day 8 [S8]) until hCG day

Secondary outcomes(13)

  1. Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose

    Time frame · Baseline (S8) until hCG day

  2. Mean Number of Ovarian Stimulation Days

    Time frame · Baseline (S8) until hCG day

  3. Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day

    Time frame · Baseline (S8) and hCG day

  4. Mean Total Number of Retrieved Oocytes

    Time frame · 34-36 hours post-hCG (OPU)

    Registry description

    Mean number of oocytes retrieved on the day of ovum pick up (OPU) was counted. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.

  5. Mean Number of Mature Oocytes (Metaphase II)

    Time frame · 34-36 hours post-hCG (OPU)

    Registry description

    Mean number of metaphase II oocytes was counted for participants undergoing ovum pick up for IntraCytoplasmic Sperm Injection (ICSI). ICSI is a procedure in which a single spermatozoon is injected into the oocyte cytoplasm. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.

  6. Fertilization Rate

    Time frame · 12-18 day post-hCG and/or Week 7

    Registry description

    Fertilization rate was measured as the ratio between number of fertilized oocytes and number of inseminated oocytes (maximum 3).

  7. Number of Obtained Embryos

    Time frame · Day 3 post-hCG (Embryo transfer [ET])

    Registry description

    Total number of obtained embryos with maximum 3 inseminated oocytes was calculated.

  8. Number of Transferred Embryos

    Time frame · Day 3 post-hCG (ET)

    Registry description

    Embryo transfer is the procedure in which one or more embryos are placed in the uterus or Fallopian tube.

  9. Percentage of Participants With Pregnancy

    Time frame · 12-18 day post-hCG and/or Week 7

  10. Percentage of Participants With Clinical Pregnancy

    Time frame · 12-18 day post-hCG and/or Week 7

    Registry description

    Clinical pregnancy is defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.

  11. Percentage of Participants With Implantation

    Time frame · 12-18 day post-hCG and/or Week 7

    Registry description

    Implantation is the attachment and subsequent penetration by the zona-free blastocyst (usually in the endometrium) that starts five to seven days after fertilization.

  12. Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)

    Time frame · Baseline (S8) until 12-18 day post-hCG and/or Week 7

    Registry description

    OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.

  13. Number of Cycles Cancelled Due to Risk of OHSS

    Time frame · Baseline (S8) until 12-18 day post-hCG and/or Week 7

    Registry description

    OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (Stimulation day 8 [S8]) until hCG day

Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes

GroupValue (IU)Spread
FSH + rhLH904.61068.1
Follicle-stimulating Hormone (FSH)703.3924.5
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (S8) until hCG day

Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose

GroupValue (IU)Spread
FSH + rhLH1434.0678.1
Follicle-stimulating Hormone (FSH)1595.0796.4
Secondary outcomeMean· Baseline (S8) until hCG day

Mean Number of Ovarian Stimulation Days

GroupValue (Days)
FSH + rhLH4.6
Follicle-stimulating Hormone (FSH)4.8
Secondary outcomeMean· Baseline (S8) and hCG day

Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day

GroupValue (picogram/milliter (pg/mL))Spread
FSH + rhLH516.1353.6
Follicle-stimulating Hormone (FSH)518.9334.2
Secondary outcomeMean· 34-36 hours post-hCG (OPU)

Mean Total Number of Retrieved Oocytes

GroupValue (oocytes)Spread
FSH + rhLH7.04.6
Follicle-stimulating Hormone (FSH)7.83.9
Secondary outcomeMean· 34-36 hours post-hCG (OPU)

Mean Number of Mature Oocytes (Metaphase II)

GroupValue (Metaphase II Oocytes)Spread
FSH + rhLH5.13.7
Follicle-stimulating Hormone (FSH)5.73.2
Secondary outcomeMean· 12-18 day post-hCG and/or Week 7

Fertilization Rate

GroupValue (ratio)Spread
FSH + rhLH0.850.29
Follicle-stimulating Hormone (FSH)0.890.20
Secondary outcomeNumber· Day 3 post-hCG (Embryo transfer [ET])

Number of Obtained Embryos

GroupValue (embryos)
FSH + rhLH142
Follicle-stimulating Hormone (FSH)158

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
FSH + rhLHFollicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).–1 / 672 / 67
Follicle-stimulating Hormone (FSH)FSH injection administered according to investigator's discretion till r-hCG administration day.–2 / 660 / 66

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Pre-menopausal infertile woman, aged 18 to 40 years inclusive, who wishes to conceive * Regular, spontaneous menstrual cycle of 25-35 days * Body mass index (BMI) ≤ 28 * FSH ≤ 10 IU/L (follicular phase, days 2-5) * Prolactin (PRL) within the normal ranges * Evidence of both ovaries by ultrasound scan * Women undergoing IVF-Embryo Transfer (ET) or ICSI, down regulated with Gonadotropin releasing hormone analogues (GnRHa) (daily dose) under controlled ovarian hyperstimulation (COH) with FSH * Washout \> 90 days from last dose of clomiphene or gonadotrophin, before ongoing COH cycle * Only one previous IVF-ET or ICSI cycle (in the last 9 months preceding the ongoing COH cycle) resulted in a hypo-response properly documented (from 6 to 12 oocytes with a total FSH dose ≥ 4000 IU) * Negative pregnancy hCG test (urine or blood sample) before the ongoing COH cycles * Willing and able to comply with the protocol for the duration of the study * Written informed consent before applying any procedure related to the study protocol, which is not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time, without prejudice on their future medical care Exclusion Criteria: * Oligo/Anovulatory cycles (World Health Organization \[WHO\] I and II) * Male partner azoospermia (assessed within the last 12 months) * Follicular phase (day 2-5) FSH \> 10 IU/L even if only once observed in the medical history * Abnormal cervical cytology (assessed within the last 12 months) * History of unexplained gynecologic hemorrhage * Any contraindication to pregnancy * Known allergy to gonadotrophin * Any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus, epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma) which constitutes a contraindication to gonadotropin use * Any medical condition which, according to the investigator's judgement, may affect the absorption, distribution, metabolism or excretion of the drug. In case of doubt, inclusion of the subject in question should be discussed with the Medical Responsible of Serono * Known Human Immunodeficiency Virus (HIV) positivity * Any substance abuse or history of drugs or alcohol abuse within the past 5 years * Prior inclusion in the present study or simultaneous inclusion in a clinical study of another drug * Refusal or inability to comply with the protocol

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