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Completed

NCT Number: NCT01507376

Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity

This study is a prospective randomized clinical trial to compare the efficacy of the urinary and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.

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Key information

Age range

20 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Royan Institute

Tehran, Iran

About this study

The study population comprised of all infertile patients aged 20-37 years which underwent of in-vitro fertilization in royan institute, Tehran Iran.

In this study all patients were treated with a long stimulation protocol in which GnRH-analogue (Buserelin subcutaneous, 0.5cc daily) was given as a pre-treatment and recombinant FSH (rFSH) administration was started when pituitary desensitization was confirmed. From the 7th day of stimulation in both groups, daily monitoring of follicle size by ultrasound was performed and the dose of rFSH was adjusted according to the response of each patient. When at least two follicles > 18 mm diameter were seen, ovulation was triggered with hCG and patients allocated into three different study groups as per the following:

  • Group A consisted of 60 women who received recombinant hCG(250 µg Ovitrelle)
  • Group B consisted of 60 women who received recombinant hCG(500 µg Ovitrelle)
  • Group C consisted of 60 patients received 10,000 IU urinary hCG Oocyte retrieval performed about 34-36 hours after hCG administration and then oocytes were assessed for nuclear maturity. Embryos transferred 2-3 days thereafter.

Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 16 for windows.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Indication for IVF/ICSI and Long Protocol ovarian stimulation
  • Age 20-37
  • Body mass index (BMI) ≤ 30 kg/m2
  • Regular menstrual cycles of 25-35 days
  • Tubal or male factor
  • Existence of both ovary and normal uterine cavity
  • Basal FSH≥10
  • Physical health

Exclusion criteria

  • Poly Cystic Ovarian Syndrome patients
  • Contraindications of gonadotropins administration
  • Poor response to ovulation induction in recent cycle

Treatment and study plan

recombinant hCG

Drug

recombinant hCG(250 µg Ovitrell)

urinary hCG

Drug

10,000 IU urinary hCG

Primary outcomes

  1. Number of mature oocytes

    Time frame: Up to1 hour after oocyte retrieval

    evaluation the effect of recombinant hcg on number of oocytes up to 1 hour after oocytes retrieval

Secondary outcomes

  1. number of retrieved oocytes per number of aspirated follicles proportion

    Time frame: up to 1 hour after oocyte retrieval

    Evaluation the effect of recombinant hCG to retrieve oocytes per number of aspirated follicles proportion

  2. fertilization rate

    Time frame: in 1 day after oocyte retrieval

    Evaluation the effect of recombinant hCG on fertilization rate in 1 day after oocyte retrieval

  3. implantation rate

    Time frame: 4 weeks after embryo transfer

    Evaluation the effect of recombinant hCG on implantation rate 4 weeks after embryo transfer

  4. OHSS occurrence rate will be compared between three groups

    Time frame: from embryo transfer day up to pregnancy test

    Evaluation the effect of recombinant hCG on OHSS occurrence rate will be compared between three groups

  5. chemical pregnancy rates

    Time frame: 2 weeks after embryo transfer

    Evaluation the effect of recombinant hCG on chemical pregnancy rates 2 weeks after embryo transfer

  6. clinical pregnancy rates

    Time frame: 4 weeks after embryo transfer

    Evaluation the effect of recombinant hCG on clinical pregnancy rates 4 weeks after embryo transfer

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Comparing the Efficacy of Urinary and Recombinant hCG on Oocyte Maturity for Ovulation Induction in Assisted Reproductive Techniques: a Randomized Clinical Trial

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jan 10, 2012
Registry last updated
Apr 25, 2014

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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