NCT01279200

Brief Summary

The purpose of this study is to investigate monitoring methods during ovulation induction cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction cycles with letrozole can be done with a variety of methods, the two most commonly utilized are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

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

Study Start

First participant enrolled

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 6, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

January 18, 2011

Results QC Date

December 18, 2014

Last Update Submit

January 5, 2015

Conditions

Infertility

Keywords

letrozoleovulation monitoringpregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Success Rate

    Percentage of women in each arm who became pregnant within the study time frame.

    3 menstrual/treatment cycles (approximately 28-33 days each)

Secondary Outcomes (1)

  • Time to Conception, Measured in Cycles

    3 menstrual/treatment cycles, or upon conception, whichever comes first

Study Arms (2)

Urinary LH Kits

ACTIVE COMPARATOR

Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).

Other: Urinary LH kits

Midcycle ultrasound + hCG injection

ACTIVE COMPARATOR

Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.

Other: Midcycle ultrasound + hCG injection

Interventions

Midcycle ultrasound + hCG injectionOTHER

Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.

Also known as: Ovidrel
Midcycle ultrasound + hCG injection
Urinary LH kitsOTHER

Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination.

Also known as: ClearBlue Easy
Urinary LH Kits

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women ages 21-39 undergoing letrozole ovulation induction (as part of routine clinical care) at a single academic-infertility center.
  • Normal uterus and evidence of at least tubal patency on one side (as assessed by saline-infusion sonography or hysterosalpingogram per clinical care).

You may not qualify if:

  • Current pregnancy
  • Nursing mothers
  • Prior hypersensitivity to hCG preparations
  • Primary ovarian failure or menopausal levels of FSH (\>12 mIU/mL)
  • Patients with abnormal uterine bleeding of undetermined origin or ovarian cyst of undetermined origin, sex-hormone dependent tumors, documented bilateral tubal obstruction, uncorrected uterine anomalies,
  • Previous letrozole or gonadotropin use and/or previous treatment with in vitro fertilization
  • Other uncorrected medical condition that would be a contraindication to attempting elective ovulation induction (e.g., uncontrolled diabetes, intracranial lesion, thyroid or adrenal disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Reproductive Medicine, University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Related Publications (7)

  • Pritts EA. Letrozole for ovulation induction and controlled ovarian hyperstimulation. Curr Opin Obstet Gynecol. 2010 Aug;22(4):289-94. doi: 10.1097/GCO.0b013e32833beebf.

    PMID: 20592587BACKGROUND

  • Mitwally MF, Casper RF. Use of an aromatase inhibitor for induction of ovulation in patients with an inadequate response to clomiphene citrate. Fertil Steril. 2001 Feb;75(2):305-9. doi: 10.1016/s0015-0282(00)01705-2.

    PMID: 11172831BACKGROUND

  • Mitwally MF, Abdel-Razeq S, Casper RF. Human chorionic gonadotropin administration is associated with high pregnancy rates during ovarian stimulation and timed intercourse or intrauterine insemination. Reprod Biol Endocrinol. 2004 Jul 7;2:55. doi: 10.1186/1477-7827-2-55.

    PMID: 15239837BACKGROUND

  • Deaton JL, Clark RR, Pittaway DE, Herbst P, Bauguess P. Clomiphene citrate ovulation induction in combination with a timed intrauterine insemination: the value of urinary luteinizing hormone versus human chorionic gonadotropin timing. Fertil Steril. 1997 Jul;68(1):43-7. doi: 10.1016/s0015-0282(97)81473-2.

    PMID: 9207582BACKGROUND

  • Zreik TG, Garcia-Velasco JA, Habboosh MS, Olive DL, Arici A. Prospective, randomized, crossover study to evaluate the benefit of human chorionic gonadotropin-timed versus urinary luteinizing hormone-timed intrauterine inseminations in clomiphene citrate-stimulated treatment cycles. Fertil Steril. 1999 Jun;71(6):1070-4. doi: 10.1016/s0015-0282(99)00116-8.

    PMID: 10360912BACKGROUND

  • Lewis V, Queenan J Jr, Hoeger K, Stevens J, Guzick DS. Clomiphene citrate monitoring for intrauterine insemination timing: a randomized trial. Fertil Steril. 2006 Feb;85(2):401-6. doi: 10.1016/j.fertnstert.2005.07.1331.

    PMID: 16595218BACKGROUND

  • Smith YR, Randolph JF Jr, Christman GM, Ansbacher R, Howe DM, Hurd WW. Comparison of low-technology and high-technology monitoring of clomiphene citrate ovulation induction. Fertil Steril. 1998 Jul;70(1):165-8. doi: 10.1016/s0015-0282(98)00119-8.

    PMID: 9660442BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Ovidrel

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Limitations and Caveats

The original intent was to study 400 women, but due to recruiting and time restraints, final enrollment was only 21. Therefore, statistical analyses of the results were eliminated, as well as some additional outcome measures originally planned for.

Results Point of Contact

Title
Senait Fisseha, MD, JD
Organization
University of Michigan
sfisseha@med.umich.edu
734-763-4323

Study Officials

  • Senait Fisseha, MD, JD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
Medical Director

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 6, 2015

Results First Posted

January 6, 2015

Record last verified: 2015-01

Locations

US(1)