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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01762111
First received: January 3, 2013
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol

Resource links provided by NLM:


Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Pregnancy rates [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Clinical pregnancy rates per cycle and per transfer


Secondary Outcome Measures:
  • Cumulative pregnancy rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Cumulative pregnancy rates including all frozen embryo transfer

  • Number of eggs [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of eggs retrieve at the end of the stimulated in-vitro fertilization cycle

  • Number of embryos [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of embryos obtain at the end of the stimulated in-vitro fertilization cycle


Estimated Enrollment: 918
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01762111     History of Changes
Other Study ID Numbers: OVO-12-22
Study First Received: January 3, 2013
Last Updated: June 21, 2013
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 20, 2014