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AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol

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ClinicalTrials.gov Identifier: NCT01762111
Recruitment Status : Suspended
First Posted : January 7, 2013
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
OVO R & D

Brief Summary:

The woman fertility decrease with the age and there is a closely link with the ovarian reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate the ovarian reserve with specific marker to have a better prediction of the response of the in vitro fertilization treatment and to have a better rate of pregnancy.

Until now, a lot of clinical criteria (age, duration of the infertility, number of antral follicles) and biological (FSH, Oestradiol, Inhibin B, EFFORT test, number of the eggs at the retrieval day) was suggested to help for the estimation of the ovarian reserve.

Since couple of years, the anti-müllerian hormone (AMH) is recognize to be one of the best ovarian reserve marker, it corresponding the number of antral follicles, it is more sensitive and predictive. Moreover, during the In-Vitro Fertilization, the anti-müllerian hormone can provide the weak responds at the stimulation and the reverse, the risk of excessive responds (hyperstimulation). To choose the gonadotropin doses to administrate (stimulation ovarian hormone) during an In-Vitro Fertilization protocol, we need to know the anti-müllerian hormone dosage. However, if the anti-müllerian hormone is recognize to evaluate the quantity of available eggs in the ovaries, his role to determine the quality of these eggs still discussed.

The goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian hormone rate on the pregnancy rate and implantation rate, during stimulate In-Vitro Fertilization protocol.


Condition or disease
Infertility

Study Type : Observational
Estimated Enrollment : 918 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol
Study Start Date : December 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources




Primary Outcome Measures :
  1. Pregnancy rates [ Time Frame: 7 weeks ]
    Clinical pregnancy rates per cycle and per transfer


Secondary Outcome Measures :
  1. Cumulative pregnancy rates [ Time Frame: 5 years ]
    Cumulative pregnancy rates including all frozen embryo transfer

  2. Number of eggs [ Time Frame: 4 weeks ]
    Number of eggs retrieve at the end of the stimulated in-vitro fertilization cycle

  3. Number of embryos [ Time Frame: 4 weeks ]
    Number of embryos obtain at the end of the stimulated in-vitro fertilization cycle



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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women followed at the clinique ovo, aged between 18 and 43 years old undergoing a stimulate In-Vitro Fertilization cycle.
Criteria

Inclusion Criteria:

  • All infertile patients aged between 18 and 43 years
  • Patients with a prescription for a stimulated In-Vitro Fertilization cycle

Exclusion Criteria:

  • Presence of endocrine disease: diabetes, hyperprolactinemia, abnormal thyroid-stimulating hormone (TSH) or Cushing syndrome
  • Renal or hepatic impairment known

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): NCT01762111


Locations
Canada, Quebec
Clinique Ovo
Montreal, Quebec, Canada, H4P 2S4
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Jacques Kadoch, MD OVO R & D

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01762111     History of Changes
Other Study ID Numbers: OVO-12-22
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by OVO R & D:
Anti-Mullerian Hormone
In-Vitro fertilization

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female