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Completed

NCT Number: NCT02108223

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

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.

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Key information

Age range

23 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fix dose r-FSH (Gonal-f)

Drug

recombinant follicle stimulation

Other names: puregon

r-LH supplementation

Drug

recombinant luteinizing hormone

Other names: luveris

r-FSH (Gonal-f)

Drug

recombinant follicle stimulation hormone

Other names: puregon

Primary outcomes

  1. Pregnancy Rate

    Time frame: Up to 9 month

    percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)

Secondary outcomes

  1. the Number of Oocytes Retrieved

    Time frame: up to 9 month

    median number of oocytes retrieved per participant

  2. Number of Mature Oocyte

    Time frame: up to 9 month

    median number of mature oocytes retrieved per participant

  3. Fertilization Rate

    Time frame: up to 9 month

    fertilization rate used to measure how many oocytes become fertilized by sperm cells

  4. Implantation Rates

    Time frame: up to 9 months

    Implantation rate is the percentage of embryos which successfully undergo implantation

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Collaborators

  • Selcuk University

Registry information

Official study 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.

Acronym: LH

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 9, 2014
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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