Back to resultsAssessment of Multiple Intrauterine Gestations From Ovarian Stimulation (AMIGOS)
Primary Purpose
Pregnancy, Unexplained Infertility
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Letrozole (aromatase inhibitor)
Clomiphene Citrate
Follicle Stimulating Hormone (gonadotropin)
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, Infertility, Ovarian stimulation, Aromatase inhibitors, Follicle Stimulating Hormone
Eligibility Criteria
Inclusion Criteria:
- Women ≥18 to ≤40 years of age, with one or more years infertility history, desirous of conceiving, regularly ovulating (defined as 9 or more menses per year), at initiation of participation.
- Normal uterine cavity and at least one open fallopian tube confirmed by hysterosalpingography (HSG), sonohysterography, or laparoscopy/hysteroscopy in the last three years preceding enrollment into the study. An uncomplicated intrauterine non-IVF pregnancy and uncomplicated delivery and postpartum course resulting in live birth within the last three years will also serve as sufficient evidence of a patent tube and normal uterine cavity as long as the subject did not have, during the pregnancy or subsequently, risk factors for Asherman's syndrome or tubal disease or other disorder leading to an increased suspicion for intrauterine abnormality or tubal occlusion.
- Evidence of ovarian function/reserve as assessed by day 3 (+/-2 days) FSH ≤12 IU/L within one year prior to study initiation.
- Normal or corrected thyroid function within one year of study initiation.
- Normal prolactin level within one year of study initiation.
- In general good health, not taking any medications which could interfere with the study (e.g., FSH, insulin sensitizers).
- Ability to have inseminations following hCG administration.
- Male partner with total motile sperm in the ejaculate of at least 5 million sperm, within one year of study initiation.
Exclusion Criteria:
- Currently pregnant or successful pregnancies within 12 months of initiating participation. Clinical intrauterine miscarriages prior to initiating participation, within ASRM guidelines: subjects over 35 must wait six months, while subjects under 35 must wait 12 months. No exclusion for biochemical pregnancies.
- Undiagnosed abnormal uterine bleeding.
- Suspicious ovarian mass.
- Patients on oral contraceptives, depo-progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially when the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins.
- Known 21-hydroxylase deficiency or other enzyme defect causing congenital adrenal hyperplasia.
- Type I or Type II diabetes mellitus, or if receiving antidiabetic medications.
- Known significant anemia (Hemoglobin <10 g/dL).
- History of deep venous thrombosis, pulmonary embolus, or cerebrovascular event.
- Known heart disease (New York Heart Association Class II or higher).
- Known Liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5 mg/dL).
- Known Renal disease (defined as BUN >30 mg/dL or serum creatinine > 1.4 mg/dL).
- History of, or suspected cervical carcinoma, endometrial carcinoma or breast carcinoma.
- History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
- Known Cushing's disease.
- Known or suspected adrenal or ovarian androgen secreting tumors.
- Allergy or contraindication to the treatment medications: AI, gonadotropins, CC or hCG.
- Couples with previous sterilization procedures (e.g. vasectomy, tubal ligation) which have been reversed.
- Patients with untreated poorly controlled hypertension defined as a systolic blood pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measures obtained at least 60 minutes apart.
- Subjects who have undergone a bariatric surgery procedure in the recent past (< 12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon.
- Known moderate or severe endometriosis
- Known polycystic ovarian syndrome as evidenced by anovulation or oligoovulation, hirsutism and/or elevated testosterone levels, and ovarian morphology on ultrasound examination.
- Donated semen.
- Couples in which either partner is legally married to someone else.
- Medical conditions that are contraindications to pregnancy.
Sites / Locations
- University of Alabama Birmingham
- University of California, San Francisco
- Stanford University Medical Center
- University of Colorado
- Yale University
- University of Michigan
- Wayne State University
- University of Medicine and Dentistry of New Jersey
- Carolinas Medical Center
- University of Oklahoma Health Sciences Center
- Pennsylvania State University College of Medicine
- University of Pennsylvania
- University of Texas Health Science Center at San Antonio
- University of Vermont
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Aromatase Inhibitors (AI)
Clomiphene Citrate (CC)
Follicle Stimulating Hormone (FSH)
Arm Description
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Outcomes
Primary Outcome Measures
Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.
Secondary Outcome Measures
Rate of Pregnancy Obtained
Time to Pregnancy
Live Birth Rate
Full Information
NCT ID
NCT01044862
First Posted
January 7, 2010
Last Updated
January 22, 2015
Sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Colorado, Denver, University of Michigan, University of Pennsylvania, University of Texas, University of Vermont, Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT01044862
Brief Title
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
Acronym
AMIGOS
Official Title
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Colorado, Denver, University of Michigan, University of Pennsylvania, University of Texas, University of Vermont, Wayne State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this application is to identify a pharmacologic agent which helps couples in whom the female partner ovulates regularly successfully obtain their goal of delivering a healthy child, whose use will result in low rates of multiple gestations. The central hypothesis is that, in infertile ovulatory women undergoing ovarian stimulation (OS) and intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the numbers of multiple gestational pregnancies that result from stimulation with clomiphene citrate (CC) or follicle stimulating hormone (FSH). The rationale for the proposed research is that reduction of multiple pregnancy rates could significantly reduce maternal and neonatal morbidity and mortality, as well as the cost of healthcare for these individuals and society.
Detailed Description
Patient Population
The population will consist of 900 women up to and including women ≥18 to ≤40 years years of age (at time of randomization) desirous of conceiving who will be recruited over approximately a two year period from the Reproductive Medicine Network (RMN) clinical sites and possibly from the Specialized Cooperative Center Programs in Reproductive Research (SCCPIR) sites, through public notification programs.
Study Design
This will be a multi-center, prospective, partially blinded clinical trial of gonadotropins vs. clomiphene citrate vs. aromatase inhibitors. The randomization scheme will be coordinated through the data coordination center (DCC) and the randomization will be stratified by each participating site and within each site for ages 18-34 and 35-40.
Treatment
Patients will be randomized to receive either FSH, CC, or an AI according to randomization tables generated by a computer randomization program. Treatment assignments will be blocked by site and age group. Subjects randomized to pill treatment will receive medication in double blinded fashion, receiving one type of pill (overcoated CC or AI). Subjects randomized to injectable medication(FSH) will receive vials of medication.
Primary efficacy parameter
Multiple gestation rate following recruitment of multiple follicular development with an AI, as compared to CC and FSH.
Secondary efficacy parameters
Rate of pregnancy obtained, live birth rate, and time to pregnancy following administration of an aromatase inhibitor, as compared to CC and FSH as well as the live birth rate of multiple gestation pregnancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Unexplained Infertility
Keywords
Pregnancy, Infertility, Ovarian stimulation, Aromatase inhibitors, Follicle Stimulating Hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
900 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aromatase Inhibitors (AI)
Arm Type
Active Comparator
Arm Description
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Arm Title
Clomiphene Citrate (CC)
Arm Type
Active Comparator
Arm Description
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Arm Title
Follicle Stimulating Hormone (FSH)
Arm Type
Active Comparator
Arm Description
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Intervention Type
Drug
Intervention Name(s)
Letrozole (aromatase inhibitor)
Intervention Description
A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate
Intervention Description
CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.
Intervention Type
Drug
Intervention Name(s)
Follicle Stimulating Hormone (gonadotropin)
Intervention Description
A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.
Primary Outcome Measure Information:
Title
Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.
Time Frame
Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks
Secondary Outcome Measure Information:
Title
Rate of Pregnancy Obtained
Time Frame
Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks
Title
Time to Pregnancy
Time Frame
Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks
Title
Live Birth Rate
Time Frame
Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women ≥18 to ≤40 years of age, with one or more years infertility history, desirous of conceiving, regularly ovulating (defined as 9 or more menses per year), at initiation of participation.
Normal uterine cavity and at least one open fallopian tube confirmed by hysterosalpingography (HSG), sonohysterography, or laparoscopy/hysteroscopy in the last three years preceding enrollment into the study. An uncomplicated intrauterine non-IVF pregnancy and uncomplicated delivery and postpartum course resulting in live birth within the last three years will also serve as sufficient evidence of a patent tube and normal uterine cavity as long as the subject did not have, during the pregnancy or subsequently, risk factors for Asherman's syndrome or tubal disease or other disorder leading to an increased suspicion for intrauterine abnormality or tubal occlusion.
Evidence of ovarian function/reserve as assessed by day 3 (+/-2 days) FSH ≤12 IU/L within one year prior to study initiation.
Normal or corrected thyroid function within one year of study initiation.
Normal prolactin level within one year of study initiation.
In general good health, not taking any medications which could interfere with the study (e.g., FSH, insulin sensitizers).
Ability to have inseminations following hCG administration.
Male partner with total motile sperm in the ejaculate of at least 5 million sperm, within one year of study initiation.
Exclusion Criteria:
Currently pregnant or successful pregnancies within 12 months of initiating participation. Clinical intrauterine miscarriages prior to initiating participation, within ASRM guidelines: subjects over 35 must wait six months, while subjects under 35 must wait 12 months. No exclusion for biochemical pregnancies.
Undiagnosed abnormal uterine bleeding.
Suspicious ovarian mass.
Patients on oral contraceptives, depo-progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially when the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins.
Known 21-hydroxylase deficiency or other enzyme defect causing congenital adrenal hyperplasia.
Type I or Type II diabetes mellitus, or if receiving antidiabetic medications.
Known significant anemia (Hemoglobin <10 g/dL).
History of deep venous thrombosis, pulmonary embolus, or cerebrovascular event.
Known heart disease (New York Heart Association Class II or higher).
Known Liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5 mg/dL).
Known Renal disease (defined as BUN >30 mg/dL or serum creatinine > 1.4 mg/dL).
History of, or suspected cervical carcinoma, endometrial carcinoma or breast carcinoma.
History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
Known Cushing's disease.
Known or suspected adrenal or ovarian androgen secreting tumors.
Allergy or contraindication to the treatment medications: AI, gonadotropins, CC or hCG.
Couples with previous sterilization procedures (e.g. vasectomy, tubal ligation) which have been reversed.
Patients with untreated poorly controlled hypertension defined as a systolic blood pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measures obtained at least 60 minutes apart.
Subjects who have undergone a bariatric surgery procedure in the recent past (< 12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon.
Known moderate or severe endometriosis
Known polycystic ovarian syndrome as evidenced by anovulation or oligoovulation, hirsutism and/or elevated testosterone levels, and ovarian morphology on ultrasound examination.
Donated semen.
Couples in which either partner is legally married to someone else.
Medical conditions that are contraindications to pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Eisenberg, MD, MPH
Organizational Affiliation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nanette Santoro, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Diamond, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Legro, MD
Organizational Affiliation
Pennsylvania State University College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
William Schlaff, MD
Organizational Affiliation
University of Colorado Denver Health Science Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gregory Christman, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christos Coutifaris, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Brzyski, MD, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Casson, MD
Organizational Affiliation
University of Vermont
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heping Zhang, PhD
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-7333
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5317
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Pennsylvania State University College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
12. IPD Sharing Statement
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26354094
Citation
Kuang H, Jin S, Thomas T, Engmann L, Hansen KR, Coutifaris C, Casson P, Christman G, Alvero R, Santoro N, Eisenberg E, Diamond MP, Legro RS, Zhang H; Reproductive Medicine Network. Predictors of participant retention in infertility treatment trials. Fertil Steril. 2015 Nov;104(5):1236-43.e1-2. doi: 10.1016/j.fertnstert.2015.08.001. Epub 2015 Sep 3.
Results Reference
derived
PubMed Identifier
25707331
Citation
Diamond MP, Legro RS, Coutifaris C, Alvero R, Robinson RD, Casson P, Christman GM, Ager J, Huang H, Hansen KR, Baker V, Usadi R, Seungdamrong A, Bates GW, Rosen RM, Haisonleder D, Krawetz SA, Barnhart K, Trussell JC, Jin Y, Santoro N, Eisenberg E, Zhang H; National Institute of Child Health and Human Development (NICHD) Reproductive Medicine Network. Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics. Fertil Steril. 2015 Apr;103(4):962-973.e4. doi: 10.1016/j.fertnstert.2014.12.130. Epub 2015 Feb 20.
Results Reference
derived
Links:
URL
http://c2s2.yale.edu/rmn/
Description
Reproductive Medicine Network Homepage
Learn more about this trial
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
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