The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI

Study Overview
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Brief Summary
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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.

Detailed Description
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Aim -We 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. We evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients. Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with infertility to the unit of Assisted Reproduction Techniques- of the Department of Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function, who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation) with rFSH were included in the study. 52 patients were considered responsive to stimulation and composed the normal control group (Group 1). On the 7th day of stimulation transvaginal ultrasonography was carried out. Patients who had at least 6 follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of <250 pg / ml were considered to have suboptimal response to stimulation and were divided into two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3 (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between the groups.

Official Title
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In This Study, the Addition of rLH, Increasing the Dose of rFSH and the Control Groups Regarding the Results of IVF in These Patients.

Conditions
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Infertility

Intervention / Treatment
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* Drug: fix dose r-FSH (Gonal-f)
* Drug: r-LH supplementation
* Drug: r-FSH (Gonal-f)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fix dose r-FSH (Gonal-f)<br>The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1 | Drug: fix dose r-FSH (Gonal-f)<br>* recombinant follicle stimulation<br>* Other names: puregon;|
| Active Comparator: r-LH supplementation to r-FSH<br>On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment. | Drug: r-LH supplementation<br>* recombinant luteinizing hormone<br>* Other names: luveris;|
| Active Comparator: r-FSH (Gonal-f)<br>Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation. | Drug: r-FSH (Gonal-f)<br>* recombinant follicle stimulation hormone<br>* Other names: puregon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Number of Oocytes Retrieved | median number of oocytes retrieved per participant | up to 9 month | 
| Number of Mature Oocyte | median number of mature oocytes retrieved per participant | up to 9 month | 
| Fertilization Rate | fertilization rate used to measure how many oocytes become fertilized by sperm cells | up to 9 month | 
| Implantation Rates | Implantation rate is the percentage of embryos which successfully undergo implantation | up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rLH, ICSI, Suboptimal Ovarian Response