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Ovarian DiseasesPhase 2FOLLPRIMNCT01310647

Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders

A Phase 2 study testing Testosterone, Estradiol and CombEq in people with Ovarian Diseases, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.

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

The aim of this study is to compare the effectiveness of testosterone,estradiol and a combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low responder patients. Read more about this study

Who is it for?
Ages 18 to 41 years, women only
Conditions the study is for
Ovarian Diseases
What is being tested?
Testosterone, Estradiol and CombEq
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSpain
Study dates
Jun 2011to Feb 2014
Phase
Phase 2
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 41 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Phase 1 (Non randomized. The patient must fit the first plus at least other 2 criteria)
  • Infertility requiring an IVF/ICSI treatment
  • Age ≥ 38 years
  • Basal FSH ≥ 10 mUI/ml (day 3 of the cycle)
  • Serum AMH ≤ 5 pmol/l
  • Antral follicular count ≤ 6 (day 3 of the cycle)
Show all 10Show fewer
  • Phase 2 (Randomized. The patient must fit at least one criterion regarding the day of GNRH analogue administration during the cycle performed in Phase 1)
  • Less than 4 follicles which mean diameter measuring more than 16mm
  • Serum estradiol levels ≤ 500 pg/ml
  • 4 MII or less than 4 MII oocytes retrieved

Who cannot join

  • Patients suffering of endometriosis
  • Patients having progesterone levels ≤ 4 ng/ml (day 21 of the cycle)
  • Patients having a partner affected by severe oligo/astheno/teratozoospermia

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • La Fe University Hospital. Department of Obstetrics and Gynecology

    Valencia, 46026

Other trials in Spain

About this study

Official title: Prospective Randomized Controlled Trial of Antral Follicle Priming Prior to IVF-ICSI in Previously Diagnosed Low Responders.

The aim of this study is to compare the effectiveness of testosterone,estradiol and a combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low responder patients.

Read the detailed description

During controlled ovarian hyperstimulation (COH), most of the early antral follicles are required to grow coordinately. Marked follicular size discrepancies during COH imply that an important number of follicles undergo unsatisfactory maturation. It has been proved that follicular priming with estradiol during the luteal phase of the cycle prior to COH or testosterone treatment during the early follicular phase of the COH cycle may increase the amount of oocytes and embryos retrieved. Nevertheless there are no prospective studies comparing such approaches. The present study consist of two phases:

The present study consists of two different phases:

  • Phase I: (Non randomized) Identification of confirmed low responder patients. Potential low responder patients will be subjected to an standardized ovarian hyperstimulation protocol
  • Phase II: (Randomized) those patients, once confirmed as low responders, will be offered the opportunity to enter the interventional part of the study, being randomized to three different treatment groups: estradiol, testosterone or combined progestagens and estrogens prior to the IVF-ICSI cycle. The previous cycle (phase I) will be used as a self-control for each patient.
Being tested
Testosterone, Estradiol, CombEq
Keywords
estradiol, testosterone, combined oral contraceptive, low responders, ICSI
Medical subject headings
Ovarian Diseases

What participants receive

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

  • TestosteroneDrug

    Also called Testopatch, Pierre Fabre Ibérica S.A.

    Transdermal testosterone (20µg/kg/day)from day 24 of the previous cycle to day 2 of the ICSI cycle

  • EstradiolDrug

    Also called Alcis 100, Chiesi España

    Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle

  • CombEqDrug

    Also called Microdiol, MERCK SHARP & DOHME, Meriestra 2mg, Novartis Farmacéutica, S.A.

    (150µg Desogestrel + 30µg Ethinylestradiol)/day during the luteal phase of the two cycles prior to the ICSI.

    Valerate estradiol 4mg/day during 10 days, starting the second day of the cycle prios to the ICSI cycle.

Study groups in NCT01310647
Study groupRoleWhat they receive
TestosteroneExperimentalTransdermal testosterone (20µg/day) from day 24 of the previous cycle until day 2 of the ICSI cycle
Receives: Drug: Testosterone
EstradiolExperimentalTransdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle
Receives: Drug: Estradiol
CombEqExperimental* (150µg Desogestrel + 30µg Ethinylestradiol)/day during the luteal phase of the two cycles prior to the ICSI * Estradiol valerate 4 mg/day during 10 days, starting the second day of the cycle prior to the ICSI cycle.
Receives: Drug: CombEq

What is being measured

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

  1. Number of MII oocytes retrieved

    Measured: 36h after GnRH analogue administration

Secondary outcomes (8)

  1. Total number of follicles punctured

    Measured: 36h after GnRH analogue administration

  2. Total number of oocytes retrieved

    Measured: 36h after GnRH analogue administration

  3. Total number of viable embryos

    Measured: 48h after follicular puncture

  4. Serum and Follicular hormonal levels (testosterone, androstenedione, estradiol)

    Measured: 36h after GnRH analogue administration

  5. Granulosa cells genetic expression profile

    Measured: 36h after GnRH analogue administration

  6. Implantation rate

    Measured: 15 days after embryo transfer

  7. Pregnancy rate

    Measured: 15 days after embryo transfer

  8. Clinical pregnancy rate

    Measured: 5 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 posted8 Mar 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2012
  4. Study completionFeb 2014

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01310647
Sponsor's protocol ID
2009-018009-26
Other IDs
2009-018009-26, 2009
Acronym
FOLLPRIM
Status last verified
Feb 2014
First submitted
7 Mar 2011
Last updated
28 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Fanchin R, Salomon L, Castelo-Branco A, Olivennes F, Frydman N, Frydman R. Luteal estradiol pre-treatment coordinates follicular growth during controlled ovarian hyperstimulation with GnRH antagonists. Hum Reprod. 2003 Dec;18(12):2698-703. doi: 10.1093/humrep/deg516.

    PubMed 14645194

  • Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.

    PubMed 19054777

  • Escriva AM, Diaz-Garcia C, Monterde M, Rubio JM, Pellicer A. Antral Follicle Priming Before Intracytoplasmic Sperm Injection in Previously Diagnosed Low Responders: A Randomized Controlled Trial (FOLLPRIM). J Clin Endocrinol Metab. 2015 Jul;100(7):2597-605. doi: 10.1210/jc.2015-1194. Epub 2015 May 8.

    PubMed 25955224

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone, Estradiol and CombEq in people with Ovarian Diseases, run by Instituto de Investigacion Sanitaria La Fe 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 10 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 28 Feb 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 MII oocytes retrieved (time frame: 36h after GnRH analogue administration). 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 NCT01310647, which also lists 3 linked publications.

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 Feb 2014.

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