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Reproductive Techniques, AssistedPhase 4GENODONNCT02625519

Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial)

A Phase 4 study testing Urinary follicle-stimulating hormone and Recombinant follicle-stimulating hormone in people with Reproductive Techniques, Assisted, run by Instituto Bernabeu at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Reproductive Techniques, Assisted
What is being tested?
Urinary follicle-stimulating hormone and Recombinant follicle-stimulating hormone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSpain
Study dates
Dec 2015to Mar 2019
Phase
Phase 4
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 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Be considered eligible to get into the oocyte donation program of Instituto Bernabeu
  • Age between 18 and 30 years
  • Body Mass Index over 18 and under 28
  • Antral follicle count greater than 9 and less than 25 (adding both ovaries)
  • Patients starting ovarian stimulation with 225 IU of FSH
  • Presence of both ovaries
Show all 9Show fewer
  • Ability to participate and comply with the study protocol
  • Signing the written consent form
  • Not having received treatment with ovulation stimulators in the 3 months prior to stimulation

Who cannot join

  • Not suitable for inclusion in the oocyte donation program of Institute Bernabeu
  • Concurrent participation in another study

Trial locations and contacts

1 site in 1 country.

Joaquín Llácer contact

965 154 000

jllacer@institutobernabeu.com

Spain1 site, 1 recruiting

  • Instituto Bernabeu

    Alicante, 03016

    Belén Lledó

    Rafel Bernabeu

    Recruiting

Other trials in Spain

About this study

Official title: Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH Versus Recombinant FSH in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism. Genodon Trial

Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism.

Read the detailed description

The aim of this study is to determine whether the number of oocytes obtained in women oocyte donors may be different with the use of rFSH or uFSH based on receptor N680S FSHR gene polymorphism.

This is an exploratory, prospective, randomized, comparative, open trial with control group treated according to the usual therapeutic approach in our institution for ovarian stimulation for oocyte donors prospective exploratory study control group .

Three groups will be set based on follicle-stimulating hormone receptor (FSHR) genotype for the polymorphism N680: Group SS (Ser/Ser), group SN (Ser/Asn) and group NN (Asn/Asn). Donor members of each group will be randomly assigned to receive daily 225 IU of recombinant or urinary FSH for controlled ovarian stimulation protocol with antagonists. To avoid unintentional bias, allocation to treatment group will take place at the time in which ovarian stimulation according begins with a list of random allocation of treatments for each of the groups (SS , SN and NN) that will be associated the code of the patient and are prepared and will be available before the start of the study. The code assignment and treatment of the patient will consecutively in the order of the list and must be recorded in the medical history of the patient. The next scheduled patient will be assigned to the code and the next immediate treatment in this list.

The protocol for controlled ovarian stimulation in oocyte donors, will be performed always according to the usual protocol in the Instituto Bernabeu.

Being tested
Urinary follicle-stimulating hormone, Recombinant follicle-stimulating hormone
Keywords
Controlled ovarian stimulation, Follicle-stimulating hormone, Receptor N680S follicle-stimulating hormone receptor (FSHR), Gene polymorphism, Oocyte donors
Medical subject headings
Helping Behavior

What participants receive

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

  • Urinary follicle-stimulating hormoneDrug

    Also called urinary FSH, Fostipur®

    Ovarian stimulation with highly purified urinary follicle-stimulating hormone

  • Recombinant follicle-stimulating hormoneDrug

    Also called recombinant FSH, Bemfola®

    Controled ovarian stimulation with recombinant follicle-stimulating hormone

Study groups in NCT02625519
Study groupRoleWhat they receive
Urinary follicle-stimulating hormoneExperimentalControled Ovarian stimulation with urinary follicle-stimulating hormone
Receives: Drug: Urinary follicle-stimulating hormone
Recombinant follicle-stimulating hormoneExperimentalOvarian stimulation with recombinant follicle-stimulating hormone
Receives: Drug: Recombinant follicle-stimulating hormone

What is being measured

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

  1. number of cumulus-oocyte complexes obtained

    number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation

    Measured: through study completion, an average of 2 weeks

Secondary outcomes (7)

  1. number of metaphase II (MII) oocytes

    number of metaphase II (MII) oocytes obtained by follicle puncture at the end of ovarian stimulation

    Measured: through study completion, an average of 2 weeks

  2. number of useful oocytes (inseminated or microinjected)

    number of useful oocytes after artificial insemination or microinjection

    Measured: through study completion, an average of 2 weeks

  3. duration of stimulation (days)

    mean number of days between the start of ovarian stimulation until the day of the follicular puncture

    Measured: through study completion, an average of 2 weeks

  4. FSH treatment units obtained by oocyte

    FSH treatment units administrated per oocyte obtained

    Measured: through study completion, an average of 2 weeks

  5. FSH treatment cost per oocyte obtained

    FSH treatment cost per oocyte obtained

    Measured: through study completion, an average of 2 weeks

  6. fertilization rate

    fertilization rate at 18 hours post-insemination

    Measured: through study completion, an average of 2 weeks

  7. occurrence of side effects

    occurrence of side effects associated with urinary FSH and recombinant FSH

    Measured: through study completion, an average of 2 weeks

Timeline

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

  1. First posted9 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionJan 2019 (estimated)
  4. Study completionMar 2019 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625519
Sponsor's protocol ID
BER-FSH-2015-01
Other IDs
2015-003779-31, 2015
Acronym
GENODON
Status last verified
Aug 2018
First submitted
9 Nov 2015
Last updated
28 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Urinary follicle-stimulating hormone and Recombinant follicle-stimulating hormone in people with Reproductive Techniques, Assisted, run by Instituto Bernabeu at 1 site in Spain.

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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Aug 2018. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Joaquín Llácer (965 154 000, jllacer@institutobernabeu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of cumulus-oocyte complexes obtained (time frame: through study completion, an average of 2 weeks). 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 NCT02625519.

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 28 Aug 2018.

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