Infertility Clinical Trial
— LHOfficial title:
In This Study, the Addition of rLH, Increasing the Dose of rFSH and the Control Groups Regarding the Results of IVF in These Patients.
Verified date | March 2015 |
Source | Sisli Etfal Training & Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
Status | Completed |
Enrollment | 137 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 23 Years to 39 Years |
Eligibility |
Inclusion Criteria: - Patients aged 23-39 - Body mass index between 18 and 30 kg/m2 - Baseline FSH =12 IU/l, E2 = 80 pg/ml - The presence of both ovaries and uterine cavity capable of sustaining a pregnancy - Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation - Who were having their first or second IVF trial. Exclusion Criteria: - Grade III-IV endometriosis - Clinically significant condition preventing them from undergoing gonadotrophin treatment - More than two previous assisted cycles - Who had a single ovary - Unexplained gynaecological bleeding - Polycystic ovary or an ovarian cyst of unknown aetiology - Previously diagnosed with a space occupying lesion like submucous myoma , polyps, septum, synechia in the uterine cavity - Have a chromosomal anomaly. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sisli Etfal Training & Research Hospital | Selcuk University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pregnancy Rate | percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml) | Up to 9 month | Yes |
Secondary | the Number of Oocytes Retrieved | median number of oocytes retrieved per participant | up to 9 month | Yes |
Secondary | Number of Mature Oocyte | median number of mature oocytes retrieved per participant | up to 9 month | Yes |
Secondary | Fertilization Rate | fertilization rate used to measure how many oocytes become fertilized by sperm cells | up to 9 month | Yes |
Secondary | Implantation Rates | Implantation rate is the percentage of embryos which successfully undergo implantation | up to 9 months | Yes |
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