Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

AMH and Dosing Regimens for Initial IVF Stimulation Protocols

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098199
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Reproductive Specialists of New York

Brief Summary:
This is a research study on a hormone in women called anti-mullerian hormone (AMH) an indicator of the amount of egg reserve in the ovaries. The research involves a blood draw to determine the AMH level. This knowledge will help the investigators decide a dosage of gonadotropins, the hormones used to stimulate the production of more than one egg for use in an in vitro fertilization (IVF) cycle. The amount of gonadotropin given has to be tailored to each individual participant. The investigators can use information about the participant and the hormone levels to determine this dosage and the chances of becoming pregnant as a result of IVF treatment. The reason the investigators are doing this research is to find out if basing the gonadotropin dosage solely on the participant's AMH level will give the investigators a better result than the previous method based on age and other hormone levels.

Condition or disease Intervention/treatment Phase
Infertility Drug: 300IU Gonal-F Drug: 150IU Menopur Drug: 225IU Gonal-F Drug: 75IU Menopur Drug: 150IU Gonal-F Drug: 75IU Gonal-F Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AMH and Dosing Regimens for Initial IVF Stimulation Protocols
Actual Study Start Date : October 22, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Menotropins

Arm Intervention/treatment
Experimental: AMH<1.5, 300IU Gonal-F + 150 IU Menopur
dosage at 300IU Gonal-F + 150IU Menopur
Drug: 300IU Gonal-F
<1.5 AMH group
Other Name: follitropin

Drug: 150IU Menopur
<1.5 AMH group
Other Name: menotropin

Experimental: AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur
dosage of 225IU Gonal-F + 75IU Menopur
Drug: 225IU Gonal-F
1.6-2.5 AMH group

Drug: 75IU Menopur
1.6-2.5 AMH group 2.6-6.9 AMH group >7.0 AMH group

Experimental: AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur
start dosage of 150IU Gonal-F and 75IU Menopur
Drug: 75IU Menopur
1.6-2.5 AMH group 2.6-6.9 AMH group >7.0 AMH group

Drug: 150IU Gonal-F
2.6-6.9 AMH group

Experimental: AMH >=7.0, 75IU Gonal-F+75U Menopur
start dosage of 75IU Gonal-F and 75U Menopur
Drug: 75IU Menopur
1.6-2.5 AMH group 2.6-6.9 AMH group >7.0 AMH group

Drug: 75IU Gonal-F
>7.0 AMH group




Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: two years ]
    Clinical pregnancy rate is defined as the number of pregnancies with the presence of an intrauterine gestational sac seen on transvaginal ultrasound by six weeks gestation divided by the number of completed embryo transfers.


Secondary Outcome Measures :
  1. Oocyte yield [ Time Frame: two years ]
    number of follicles produced



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • first cycle of IVF with transfer of fresh embryo

Exclusion Criteria:

  • use of non-autologous oocytes; prior diagnosis of premature ovarian failure or diminished ovarian reserve; BMI>= 40; cryopreservation cycles; smokers; use of PGS/PGD; use of surgically retrieved sperm or patients with severe male factor; and oocyte- or embryo-banking cycles

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098199


Sponsors and Collaborators
Reproductive Specialists of New York
Investigators
Layout table for investigator information
Principal Investigator: Linda Sung, MD Reproductive Specialists of New York
Publications:

Layout table for additonal information
Responsible Party: Reproductive Specialists of New York
ClinicalTrials.gov Identifier: NCT03098199    
Other Study ID Numbers: 597102-3
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reproductive Specialists of New York:
Antimullerian Hormone
In vitro fertilization
Medications
Dosing
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Menotropins
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents