NCT02069808

Brief Summary

Disprove the null hypothesis as follows: Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below, use of adjunctive LH activity medication Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as from egg donors not treated with Menopur™. Objectives: Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity medication Menopur ™ for our volunteer egg bank donors. Efficacy defined as:

  1. 1.#Days of ovarian stimulation to GnRH agonist trigger.
  2. 2.Peak serum estradiol level on day of GnRH agonist trigger.
  3. 3.Number of follicles \>15 mm average diameter on day of GnRH agonist trigger.
  4. 4.Number of mature oocytes recovered and cryopreserved.
  5. 5.#Days of ovarian stimulation to GnRH agonist trigger.
  6. 6.Peak serum estradiol level on day of GnRH agonist trigger.
  7. 7.Number of follicles \>15 mm average diameter on day of GnRH agonist trigger.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2017

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

February 19, 2014

Last Update Submit

March 21, 2018

Conditions

Egg Donation

Outcome Measures

Primary Outcomes (1)

  • number of mature oocytes recovered and cryopreserved.

    Immediately after egg harvest, The embyrologist performed microscopic examination of oocytes and is able to determine if the oocyte has completed meiosis 1 with the extrusion of the first polar body and has entered the second stage of meiosis. An oocyte of this developmental stage is considered mature and receptive to a sperm.

    2 weeks

Secondary Outcomes (3)

  • 1) #Days of ovarian stimulation to GnRH agonist trigger.

    2 weeks

  • 2) Peak serum estradiol level on day of GnRH agonist trigger

    2 weeks

  • Number of follicles >15 mm average diameter on day of GnRH agonist trigger

    2 weeks

Study Arms (2)

Group B: Follistim and Menopur

EXPERIMENTAL

Group B: N=25 subjects 1. Cycle day 2 start Follistim 200 U/day up to 11 days duration. 2. Cycle day 2 start Menopur (menotropins) 75 U/day up to 11 days duration. 3. Add GnRH antagonist Ganirelix 250 µg/day starting 5 days before GnRH agonist trigger. 4. GnRH agonist Leuprolide Acetate (Lupron) 1 mg subcutaneous injection 36 hours prior to egg collection. 5. Transvaginal ultrasound guided needle aspiration of oocytes 36 hours after Lupron trigger.

Drug: FollistimDrug: GanirelixDrug: MenotropinsDrug: LeuprolideProcedure: Transvaginal ultrasound guided needle aspiration of oocytes

Group A: Follistim only

ACTIVE COMPARATOR

Group A: N=25 subjects 1. Cycle day 2 start Follistim 250 U/day up to 11 days duration. 2. Add GnRH antagonist Ganirelix 250 µg/day starting 5 days before GnRH agonist trigger. 3. GnRH agonist Leuprolide Acetate (Lupron) 1 mg subcutaneous injection 36 hours prior to egg collection. 4. Transvaginal ultrasound guided needle aspiration of oocytes 36 hours after Lupron trigger.

Drug: FollistimDrug: GanirelixDrug: LeuprolideProcedure: Transvaginal ultrasound guided needle aspiration of oocytes

Interventions

FollistimDRUG

Follicle stimulating hormone promotes recruitment of follicles for ovulation.

Also known as: Follistim AQ
Group A: Follistim onlyGroup B: Follistim and Menopur
GanirelixDRUG

GnRH antagonist preventing a problematic risk of premature LH surge during ovulation induction therapy.

Also known as: Ganirelix Acetate
Group A: Follistim onlyGroup B: Follistim and Menopur
MenotropinsDRUG

Combination of follicle stimulating hormone and Luteinizing hormone activity promotes recruitment of follicles for ovulation. Absence or presence of this medication is the difference being tested between the two arms of the study.

Also known as: Menopur
Group B: Follistim and Menopur
LeuprolideDRUG

Promotes endogenous LH surge signaling oocyte maturation followed by ovulation. This controls timing for oocyte collection.

Also known as: Lupron, Leuprolide acetate
Group A: Follistim onlyGroup B: Follistim and Menopur
Transvaginal ultrasound guided needle aspiration of oocytesPROCEDURE
Group A: Follistim onlyGroup B: Follistim and Menopur

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient selection: women volunteers in good health wishing to serve as egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 28 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH \<10 mIU/ml. AMH \>2.0 ng/ml.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Reproductive Medicine

Bloomfield Hills, Michigan, 48304-5130, United States

Location

MeSH Terms

Interventions

follitropin betaGlycoprotein Hormones, alpha SubunitganirelixMenotropinsLeuprolide

Intervention Hierarchy (Ancestors)

Chorionic GonadotropinGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsFollicle Stimulating HormoneGonadotropins, PituitaryLuteinizing HormonePituitary Hormones, AnteriorPituitary HormonesThyrotropinPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex MixturesGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesNeuropeptidesOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Michael S Mersol-Barg, MD

    Michigan Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 24, 2014

Study Start

April 1, 2014

Primary Completion

February 12, 2017

Study Completion

March 8, 2017

Last Updated

March 23, 2018

Record last verified: 2018-03

Locations

US(1)