Clinical trial NCT01762111: AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol
Official title: AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility
Keywords: Anti-Mullerian Hormone
In-Vitro fertilization
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Pregnancy rates
timeFrame: 7 weeks
Secondary outcomes:
measure: Cumulative pregnancy rates
timeFrame: 5 years
measure: Number of eggs
timeFrame: 4 weeks
measure: Number of embryos
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References: