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In Vitro FertilizationPhase 3NCT01507376

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

A Phase 3 study testing recombinant hCG and urinary hCG in people with In Vitro Fertilization, run by Royan Institute at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 37 years, women onlyHealthy volunteers can take part
Conditions the study is for
In Vitro Fertilization
What is being tested?
recombinant hCG and urinary hCG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteIran
Study dates
Oct 2010to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 37 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Royan Institute

    Tehran

Other trials in Iran

About this study

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

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.

Read the detailed description

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:

  1. Group A consisted of 60 women who received recombinant hCG(250 µg Ovitrelle)
  2. Group B consisted of 60 women who received recombinant hCG(500 µg Ovitrelle)
  3. 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.

Being tested
recombinant hCG, urinary hCG
Keywords
Ovulation induction, urinary, hCG, recombinant hCG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant hCGDrug

    recombinant hCG(250 µg Ovitrell)

  • recombinant hCGDrug

    recombinant hCG(500 µg Ovitrell)

  • urinary hCGDrug

    10,000 IU urinary hCG

Study groups in NCT01507376
Study groupRoleWhat they receive
A: recombinant hCG(250 µg Ovitrell)Experimental1- Group A consisted of 60 infertile women who received recombinant hCG(250 µg Ovitrelle)
Receives: Drug: recombinant hCG
B: recombinant hCG(500 µg Ovitrell)Experimental2- Group B consisted of 60 infertile women who received recombinant hCG(500 µg Ovitrelle)
Receives: Drug: recombinant hCG
C: urinary hCGExperimental3- Group C consisted of 60 infertile patients received 10,000 IU urinary hCG
Receives: Drug: urinary hCG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of mature oocytes

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

    Measured: Up to1 hour after oocyte retrieval

Secondary outcomes (6)

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

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

    Measured: up to 1 hour after oocyte retrieval

  2. fertilization rate

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

    Measured: in 1 day after oocyte retrieval

  3. implantation rate

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

    Measured: 4 weeks after embryo transfer

  4. OHSS occurrence rate will be compared between three groups

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

    Measured: from embryo transfer day up to pregnancy test

  5. chemical pregnancy rates

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

    Measured: 2 weeks after embryo transfer

  6. clinical pregnancy rates

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

    Measured: 4 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2012 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2012
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01507376
Sponsor's protocol ID
Royan-Emb-012
Status last verified
Oct 2010
First submitted
14 Sep 2011
Last updated
25 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Madani T, Mohammadi Yeganeh L, Ezabadi Z, Hasani F, Chehrazi M. Comparing the efficacy of urinary and recombinant hCG on oocyte/follicle ratio to trigger ovulation in women undergoing intracytoplasmic sperm injection cycles: a randomized controlled trial. J Assist Reprod Genet. 2013 Feb;30(2):239-45. doi: 10.1007/s10815-012-9919-3. Epub 2012 Dec 29.

    PubMed 23274511

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing recombinant hCG and urinary hCG in people with In Vitro Fertilization, run by Royan Institute at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of mature oocytes (time frame: Up to1 hour after oocyte retrieval). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01507376, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.

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