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

NCT02108223 | Completed Phase 4 Results DMC

• 1 other identifier: 4085
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Keywords

ICSI; Suboptimal Ovarian Response; rLH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the Number of Oocytes Retrieved

  up to 9 month

• Number of Mature Oocyte

  up to 9 month

• Fertilization Rate

  up to 9 month

• Implantation Rates

  up to 9 months

Study Arms (3)

fix dose r-FSH (Gonal-f)

ACTIVE COMPARATOR

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)

r-LH supplementation to r-FSH

ACTIVE COMPARATOR

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

r-FSH (Gonal-f)

ACTIVE COMPARATOR

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)

Interventions

fix dose r-FSH (Gonal-f) DRUG

recombinant follicle stimulation

Also known as: puregon

fix dose r-FSH (Gonal-f)

r-LH supplementation DRUG

recombinant luteinizing hormone

Also known as: luveris

r-LH supplementation to r-FSH

r-FSH (Gonal-f) DRUG

recombinant follicle stimulation hormone

Also known as: puregon

r-FSH (Gonal-f)

Eligibility Criteria

• Age: 23 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead
• Selcuk University: collaborator

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; follitropin beta; Luteinizing Hormone, beta Subunit

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Fatma yazıcı yılmaz
• Organization: Sisli etfal training anf research hospital

fatmayazc@gmail.com

+905079234033

Study Officials

• fatma yazıcı yılmaz, MD

  Sisli Etfal training and research hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 9, 2014
• Study Start: January 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 20, 2015
• Results First Posted: August 19, 2014

Record last verified: 2015-03