Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation (AMIGOS)

This study has been completed.
Sponsor:
Collaborators:
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Information provided by (Responsible Party):
Heping Zhang, Yale University
ClinicalTrials.gov Identifier:
NCT01044862
First received: January 7, 2010
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Pregnancy
Unexplained Infertility
Interventions: Drug: Letrozole (aromatase inhibitor)
Drug: Clomiphene Citrate
Drug: Follicle Stimulating Hormone (gonadotropin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aromatase Inhibitors (AI)

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.

Letrozole (aromatase inhibitor): 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.

Clomiphene Citrate (CC)

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.

Clomiphene Citrate: 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.

Follicle Stimulating Hormone (FSH)

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.

Follicle Stimulating Hormone (gonadotropin): 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.


Participant Flow:   Overall Study
    Aromatase Inhibitors (AI)     Clomiphene Citrate (CC)     Follicle Stimulating Hormone (FSH)  
STARTED     299     300     301  
COMPLETED     246     251     249  
NOT COMPLETED     53     49     52  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Aromatase Inhibitors (AI)

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.

Letrozole (aromatase inhibitor): 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.

Clomiphene Citrate (CC)

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.

Clomiphene Citrate: 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.

Follicle Stimulating Hormone (FSH)

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.

Follicle Stimulating Hormone (gonadotropin): 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.

Total Total of all reporting groups

Baseline Measures
    Aromatase Inhibitors (AI)     Clomiphene Citrate (CC)     Follicle Stimulating Hormone (FSH)     Total  
Number of Participants  
[units: participants]
  299     300     301     900  
Age  
[units: years]
Mean (Standard Deviation)
  32.2  (4.3)     32.0  (4.6)     32.2  (4.1)     32.2  (4.4)  
Gender  
[units: participants]
       
Female     299     300     301     900  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     299     300     301     900  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Heping Zhang, PhD
Organization: Yale University
phone: 203-785-5185
e-mail: heping.zhang@yale.edu


No publications provided


Responsible Party: Heping Zhang, Yale University
ClinicalTrials.gov Identifier: NCT01044862     History of Changes
Other Study ID Numbers: RMN-AMIGOS, 3U10HD055925-02S1, 5U10HD055925, 3U10HD039005-08S1, 5U10HD039005
Study First Received: January 7, 2010
Results First Received: January 6, 2015
Last Updated: January 22, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration