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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: fix dose r-FSH (Gonal-f); Drug: r-LH supplementation; Drug: r-FSH (Gonal-f)

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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fix dose r-FSH (Gonal-f); 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); recombinant follicle stimulation; Other Names: puregon
Active Comparator: r-LH supplementation to r-FSH; 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; recombinant luteinizing hormone; Other Names: luveris
Active Comparator: r-FSH (Gonal-f); 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); recombinant follicle stimulation hormone; Other Names: puregon

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Collaborators: Selcuk University
• Investigators: Principal Investigator: fatma yazıcı yılmaz, MD, Sisli Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: ICSI; Suboptimal Ovarian Response; rLH
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 4085