Infertility
Conditions
Keywords
In Vitro Fertilization, ovulation induction, anti-mullerian hormone
Brief summary
The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to identify women at risk of excessive and poor response in controlled ovarian stimulation (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized COS strategies in these subsets of patients.
Detailed description
A group of 130 women undergoing conventional COS after pituitary down-regulation for IVF will be studied to determine the best cut-off points of AMH, using receiver operating characteristic (ROC) analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved). The inclusion criteria is any patient with indication of IVF treatment. Subsequently, a different group of 120 women (with the same criteria) will be assessed using AMH before starting COS, and treatment strategy will be individualized according to AMH results (iCOS). Mild stimulation using daily doses (112.5 to 150 IU) of recombinant follicle stimulation hormone (rec-hFSH) or rec-hFSH combined with recombinant luteinizing hormone (LH) supplementation (375 IU total daily dose) will be given to patients identified as at risk of excessive and poor response, respectively. It will evaluated: number of oocytes, clinical pregnancy rates (defined as fetal heartbeat on ultrasound performed 4 weeks after the transfer of embryos) and occurrence of Ovarian hyperstimulation syndrome). Outcomes will be compared between the groups who received conventional and iCOS using chi-square and Fisher exact tests.
Interventions
a protocol of ovarian stimulation with recombinant FSH with dose according to age, ovarian size and previous treatment. In patients alder than 35, recombinant LH was added to ovarian stimulation.
OTHERindividualized ovarian stimulation
After defining cut-off points of anti-mullerian hormone, using a ROC analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved), a individualized protocol was defined.Mild stimulation using daily doses (112.5 to 150 IU) of recombinant FSH or recombinant FSH combined with recombinant LH supplementation (375 IU total daily dose) were given to patients identified as at risk of excessive and poor response.
Sponsors
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women with in vitro fertilization treatment indication
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of oocytes retrieved | 1 day (on the day of oocyte retrieval) | number of oocyte retrieved classified as: poor response: ≤4 oocytes normal response: 5 - 19 oocytes excessive response: ≥20 oocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate | 4 weeks after embryo transfer | presence of fetal heartbeat on transvaginal ultrasound |
| occurrence of ovarian hyperstimulation syndrome | 4 weeks after embryo transfer | presence of hyperstimulation syndrome during follow up after oocyte retrieval |
| cancellation | on the 8th day of ovarian stimulation | cancellation of the cycle because of no ovarian response (no follicles \>14 mm during ovarian stimulation) |
Countries
Brazil
Outcome results
None listed