NCT01075815

Brief Summary

This is a multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms of improved embryo competence which allows to transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy rate.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 20, 2012

Completed
Last Updated

February 13, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

February 24, 2010

Results QC Date

August 29, 2012

Last Update Submit

January 20, 2014

Conditions

InfertilityOvulation Induction

Keywords

InfertilityOvulation inductionLuverisControlled ovarian stimulationReproductive technologies, assisted

Outcome Measures

Primary Outcomes (1)

  • Implantation Rate

    Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.

    Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])

Secondary Outcomes (15)

  • Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day

    r-hCG day (end of stimulation cycle [approximately 28 days])

  • Mean Number of Oocytes Retrieved

    34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])

  • Number of Mature Oocytes Retrieved

    34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])

  • Number of Fertilized Oocytes (2 Pronuclei [PN])

    34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])

  • Number and Quality of Embryos

    Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])

  • +10 more secondary outcomes

Study Arms (2)

rFSH + rhLH

EXPERIMENTAL

Recombinant human luteinizing hormone (rhLH,Luveris®) injection 150 IU subcutaneously daily along with rFSH 300 IU subcutaneously daily from S1 to S4 and then rFSH dose can be adjusted depending on the ovarian response till r-hCG administration day.

Drug: Recombinant human luteinizing hormone (rhLH)Drug: Recombinant follicle-stimulating hormone (rFSH)

rFSH

ACTIVE COMPARATOR

rFSH injection 300 IU subcutaneously daily from S1 to S4 and then dose can be adjusted depending on the ovarian response till r-hCG administration day.

Drug: Recombinant follicle-stimulating hormone (rFSH)

Interventions

Recombinant human luteinizing hormone (rhLH)DRUG
Also known as: Luveris®, Lutropin alfa
rFSH + rhLH
Recombinant follicle-stimulating hormone (rFSH)DRUG
rFSHrFSH + rhLH

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-menopausal female subject aged greater than (\>) 35 years
  • Subjects with baseline FSH serum level less than or equal to (\<=) 10 IU/liter (l), LH and E2 levels within local normal range and plasma prolactin levels \< 30 nanogram/milliliter (ng/ml)
  • Subjects with regular spontaneous menstrual cycles of 25-35 days
  • Subjects with infertility justifying IVF/ICSI-ET treatment
  • Subjects programmed for COS with r-FSH under GnRH agonist protocol
  • Sperm from current male partner suitable for IVF/ICSI according to local lab, unless sperm donor is foreseen
  • Subjects with presence of both ovaries
  • Subjects whose uterine cavity is able to sustain embryo implantation or pregnancy
  • Subjects with normal papanicolaou test (PAP) smear within previous 3 years
  • Subjects with body mass index (BMI) \< 30 at stimulation start
  • Subjects who receive confirmation of not being pregnant by a negative beta-hCG test (urine or blood) prior to starting r-FSH administration
  • Subjects willing and able to comply with the protocol for the duration of the study
  • Subjects who have given informed consent prior to any study-related procedure not part of normal medical care

You may not qualify if:

  • Subjects or her male partners who are known to be human immunodeficiency virus, hepatitis B virus or hepatitis C virus positive
  • Subjects with any clinically significant systemic disease; tumors of the hypothalamus and pituitary gland; ovarian, uterine or mammary cancer; hormonal abnormality and/or medical, biochemical, hematological condition which in the judgment of the investigator may interfere with gonadotropin treatment
  • Subjects with more than 2 previous assisted reproductive technologies (ART) cycles
  • Subjects in which previous cycles were cancelled due to poor response (\< 3 antral follicles after 15 day of stimulation)
  • Subjects with cryopreserved embryos from previous ART cycles
  • Subjects with unexplained gynecological bleeding
  • Subjects with polycystic ovaries, ovarian enlargement or cyst of unknown etiology
  • Subjects known to have any contraindication to being pregnant and/or carrying pregnancy to term
  • Subjects with known allergy to gonadotrophin preparations or any of the excipients
  • Subjects known to have any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years
  • Subjects with previous entry into this study or simultaneous participation in another clinical drug trial
  • Subjects who have refused to or inability to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FivMadrid, C/ Marqués de Urquijo, 26,

Madrid, 28008, Spain

Location

MeSH Terms

Conditions

InfertilityHelping Behavior

Interventions

Luteinizing Hormone, beta SubunitGlycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Luteinizing HormoneGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsChorionic GonadotropinFollicle Stimulating HormoneThyrotropinPlacental Hormones

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Serono, a division of Merck KGaA
service@merckgroup.com
+49-6151-72-5200

Study Officials

  • Medical Responsible

    Merck, S.L., Spain

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 13, 2014

Results First Posted

November 20, 2012

Record last verified: 2014-01

Locations

ES(1)