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Use of High Cost Monitoring During Letrozole Ovulation Induction

Primary Purpose

Infertility

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Midcycle ultrasound + hCG injection

Urinary LH kits

About this trial

This is an interventional treatment trial for Infertility focused on measuring letrozole, ovulation monitoring, pregnancy rate

Eligibility Criteria

21 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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).

Sites / Locations

Center for Reproductive Medicine, University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Urinary LH Kits

Midcycle ultrasound + hCG injection

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pregnancy Success Rate

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

Secondary Outcome Measures

Time to Conception, Measured in Cycles

Cycles means treatment/menstrual cycles, approximately 28-33 days.

Full Information

NCT ID

NCT01279200

First Posted

January 18, 2011

Last Updated

January 5, 2015

Sponsor

University of Michigan

Collaborators

Blue Cross Blue Shield of Michigan Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01279200

Brief Title

Use of High Cost Monitoring During Letrozole Ovulation Induction

Official Title

Use of High Cost Monitoring During Letrozole Ovulation Induction and Effect on Pregnancy Rates - A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

Blue Cross Blue Shield of Michigan Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

The study will be a randomized controlled trial of adult women with primary and secondary infertility seen at the University of Michigan Health System undergoing ovulation induction (OI) with letrozole as part of their standard clinical care. Patients who are undergoing OI with letrozole as per standard clinical care will be randomized to urinary luteinizing hormone (LH) ovulation predictor kit use versus mid-cycle ultrasound with administration of hCG when appropriate for timing of intercourse or intrauterine insemination. Patients who have been prescribed letrozole as per routine clinical care will be approached to determine willingness to participate in this study. Study period involves up to three ovulation induction cycles or until pregnancy occurs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

letrozole, ovulation monitoring, pregnancy rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Urinary LH Kits

Arm Type

Active Comparator

Arm Description

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

Arm Title

Midcycle ultrasound + hCG injection

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Midcycle ultrasound + hCG injection

Other Intervention Name(s)

Ovidrel

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Urinary LH kits

Other Intervention Name(s)

ClearBlue Easy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pregnancy Success Rate

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Time to Conception, Measured in Cycles

Description

Cycles means treatment/menstrual cycles, approximately 28-33 days.

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Senait Fisseha, MD, JD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Reproductive Medicine, University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48108

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20592587

Citation

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.

Results Reference

background

PubMed Identifier

11172831

Citation

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.

Results Reference

background

PubMed Identifier

15239837

Citation

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.

Results Reference

background

PubMed Identifier

9207582

Citation

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.

Results Reference

background

PubMed Identifier

10360912

Citation

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.

Results Reference

background

PubMed Identifier

16595218

Citation

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.

Results Reference

background

PubMed Identifier

9660442

Citation

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.

Results Reference

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Use of High Cost Monitoring During Letrozole Ovulation Induction

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