Clinical trial NCT02108223: The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: ICSI
Suboptimal Ovarian Response
rLH
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Selcuk University
First posted: 2014-04-09
Enrollment: 137
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 1. 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.
2. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pregnancy Rate
timeFrame: Up to 9 month
Secondary outcomes:
measure: the Number of Oocytes Retrieved
timeFrame: up to 9 month
measure: Number of Mature Oocyte
timeFrame: up to 9 month
measure: Fertilization Rate
timeFrame: up to 9 month
measure: Implantation Rates
timeFrame: up to 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Sisli Etfal training and research hospital
name: fatma yazıcı yılmaz, MD
role: PRINCIPAL_INVESTIGATOR
References: