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

NCT ID: NCT02108223

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

Infertility

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

fix dose r-FSH (Gonal-f)

Intervention Type: DRUG

recombinant follicle stimulation

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.

Group Type: ACTIVE_COMPARATOR

r-LH supplementation

Intervention Type: DRUG

recombinant luteinizing hormone

r-FSH (Gonal-f)

Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.

Group Type: ACTIVE_COMPARATOR

r-FSH (Gonal-f)

Intervention Type: DRUG

recombinant follicle stimulation hormone

Interventions

fix dose r-FSH (Gonal-f)

recombinant follicle stimulation

Intervention Type: DRUG

r-LH supplementation

recombinant luteinizing hormone

Intervention Type: DRUG

r-FSH (Gonal-f)

recombinant follicle stimulation hormone

Intervention Type: DRUG

Other Intervention Names

puregon; luveris; puregon

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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: collaborator

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

fatma yazıcı yılmaz

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

fatma yazıcı yılmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Sisli Etfal training and research hospital

Other Identifiers

4085

Identifier Type: -

Identifier Source: org_study_id