Infertility, FemalePhase 3TESTOPRIMNCT03378713

Clinical Trial to Assess the Effect of Testosterone in Patients With Poor Ovarian Response (TESTOPRIM)

A Phase 3 study testing GROUP 1: Long testosterone and GROUP 2: Short testosterone in people with Infertility, Female, 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

Trial to determine the absolute and relative efficacy of two follicular preparation regimens with transdermal testosterone during the cycle (s) prior to the initiation of COS (controlled ovarian stimulation) in patients diagnosed with POR (poor ovarian response) for the increase in the number of mature oocytes… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Infertility, Female
What is being tested?: GROUP 1: Long testosterone and GROUP 2: Short testosterone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteSpain
Study dates: 7 Aug 2017to 11 Feb 2019
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed Informed consent prior to the completion of any procedure related to the clinical trial.
Female older than 18 years old at the time of randomization.
Prior diagnosis of poor ovarian response (POR) according to ESHRE Bologna criteria. Patients must meet at least 2 of the following:
Advanced maternal age (40 years or more) or any other risk factor for POR.
A previous POR (3 oocytes or less) with a conventional ovarian stimulation protocol.
Abnormal ovarian reserve test (RFA <5-7 or AMH 3.3-7.9 pmol / l).

Who cannot join

Presence of uterine malformations, corrected or not.
Presence of uterine pathology defined as submucous myomas or endometrial polyps, documented by transvaginal ultrasound.
Couples with severe male factor defined as REM <1 or azoospermia.
Hydrosalpinx unilateral or bilateral uncorrected.
Perimenopausal patients with irregular menstrual cycles.
Concurrent untreated endocrine disorders.

Show all 10Show fewer

Patients who have participated in a clinical trial in a period of less than one month.
Known allergy to the drug.
Patients who have received androgen treatment within 3 months prior to inclusion in the study.
BMI> 35 kg / m2

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario y Politécnico La Fe
Valencia, 46026

Other trials in Spain

About this study

Official title: Clinical Effect of Follicular Preparation With Testosterone in Poor Ovarian Response: a Randomized Controlled Clinical Trial (TESTOPRIM)

Read the detailed description

POR is a challenge for reproductive medicine because of its impact on treatment outcomes and the lack of sufficiently proven therapeutic tools. According to recent publications based on retrospective studies of large registries, there is a correlation between the number of oocytes and LBR (live birth rate), so the investigators consider that variable mature oocytes are a reasonable compromise and a solid substitute for other outcome variables such as LBR or CPR (clinical pregnancy rate).

Regarding the duration of treatment, the investigators decided to include two groups of testosterone treatment (compared to the control group) with different duration. One will explore the role of testosterone in prolonged treatments (two full menstrual cycles). The other will test the pattern most commonly used in most studies, that is, testosterone in luteal phase of the previous cycle (about 10 days in short protocol with GnRH antagonist). In this way the investigators will establish an absolute comparison with the control group and relative between both treatment groups (long testosterone vs. short testosterone) to determine if / which of the two regimen (the two, only one or none) improves the number of mature oocytes recovered.

The product under investigation is testosterone gel, transdermal administration, 50 mg / single dose (Testim®, Ferring, Madrid, Spain). Regarding the dose, the investigators decided to keep the most used in the rest of studies (12.5 mg / day).

This study population will include only patients diagnosed with POR based on ESHRE Bologna criteria, in order to homogenize the population and allow comparisons with other studies in the future.

Regarding the dose, the investigators decided to keep the most used in the rest of studies (12.5 mg/day) which so far has been the only one proven effective. It is clearly possible that lower and more physiological doses are equally effective, but this yet has to be proven in well-designed studies. The gel is self-administered by the patients who are adequately instructed by a research nurse.

Conditions: Infertility, Female
Being tested: GROUP 1: Long testosterone, GROUP 2: Short testosterone, GROUP 3: Control
Keywords: Poor Ovarian Response
Medical subject headings: Infertility, Female

What participants receive

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

GROUP 1: Long testosteroneDrug
Application of testosterone in transdermal gel during the 2 cycles prior to initiation of controlled ovarian stimulation and until the onset of second menstruation (approximately 56 days). The COS begins the day after the last testosterone application
GROUP 2: Short testosteroneDrug
Application of testosterone in transdermal gel begins on day 21 of menstrual cycle, from the luteal phase of the cycle prior to initiation of controlled ovarian stimulation and until menstruation (approximately 10 days). The COS begins the day after the last testosterone application.
GROUP 3: ControlDrug
The COS starts directly on the second day of the cycle without prior medication.

Study groups in NCT03378713
Study group	Role	What they receive
GROUP 1: Long testosterone	Experimental	Application of testosterone in transdermal gel during the 2 cycles prior to initiation of controlled ovarian stimulation and until the onset of second menstruation (approximately 56 days). The COS begins the day after the last testosterone application. Receives: Drug: GROUP 1: Long testosterone
GROUP 2: Short testosterone	Active comparator	Application of testosterone in transdermal gel begins on day 21 of menstrual cycle, from the luteal phase of the cycle prior to initiation of controlled ovarian stimulation and until menstruation (approximately 10 days). The COS begins the day after the last testosterone application. Receives: Drug: GROUP 2: Short testosterone
GROUP 3: Control	Active comparator	The COS starts directly on the second day of the cycle without prior medication. Receives: Drug: GROUP 3: Control

What is being measured

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

Total number of mature oocytes obtained at follicular puncture.
Determining whether a Follicular preparation with transdermal testosterone increases the number of mature oocytes retrieved in patients diagnosed with Poor Ovarian Response and which testosterone administration regimen is more effective for this purpose.
Measured: 36 hours after induction of ovulation with recombinant HCG.

Secondary outcomes (17)

Number of obtained embryos
Measured: 6 days after ovarian puncture.
Number of antral follicles at the start of stimulation
Measured: Time E: prior to controlled ovarian stimulation (at the beginning of the third cycle after inclusion and randomization, approximately 56 days after Day 0)
Initiation rate
Quotient between the number of patients initiating COS and the total number of patients, overall and in each group
Measured: Time E: prior to controlled ovarian stimulation (at the beginning of the third cycle after inclusion and randomization, approximately 56 days after Day 0)
Number of days of stimulation duration
Measured: Time P (time of follicular puncture): 36 hours after the induction
Number of total follicles and greater than 16 mm
Measured: Time I (Day of induction): 10-12 days after controlled ovarian stimulation
Total dose of gonadotrophins used
Measured: Time I (Day of induction): 10-12 days after controlled ovarian stimulation
Cancellation rate due to lack of ovarian response
Measured: Time C: 10-12 days after controlled ovarian stimulation
Number of cumulus-oocyte complexes recovered on day of follicular puncture
Measured: Time P (time of follicular puncture): 36 hours after the induction
Fertilization rate
Measured: 24 hours after the puncture
Rate of cycles that achieve embryo transfer
Measured: Time ET ( day of embryo transfer): 4-5 days after the stimulation
Number of good quality embryos available
Measured: 48-72 hours after puncture
Number of embryos transferred
Measured: Time ET (day of embryo transfer): 4-5 days after the stimulation
Number of cycles with supernumerary embryos to freeze
Measured: 6 days after embryo transfer
Ongoing pregnancy rate per cycle started and per transfer
Measured: 70-75 days after embryo transfer
Clinical pregnancy rate per cycle started and per transfer
Measured: 30-35 days after embryo transfer
Miscarriage rate
Measured: At 11-13 weeks of pregnancy, if there is no previous news of the patient (Trial completion time)
Serum hormone levels
Serum hormone levels of FSH, LH, E2, progesterone, testosterone, androstenedione, DHEA, SHBG and FAI
Measured: Day 0; Time I (day of induction): 10-12 days after controlled ovarian stimulation; and Time E (prior to controlled ovarian stimulation: at the beginning of the third cycle after inclusion and randomization, approximately 56 days after Day 0)

Timeline

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

7 Aug 201711 Feb 2019

First posted20 Dec 2017
Study start7 Aug 2017
Primary completion11 Feb 2019
Study completion11 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Infertility, FemaleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Single blind
Who is masked: Investigator
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03378713
Sponsor's protocol ID: TESTOPRIM
Acronym: TESTOPRIM
Status last verified: Feb 2019
First submitted: 30 Nov 2017
Last updated: 13 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Tarlatzis BC, Zepiridis L, Grimbizis G, Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update. 2003 Jan-Feb;9(1):61-76. doi: 10.1093/humupd/dmg007.
PubMed 12638782
Gorgy A, Naumann N, Bates S, Craft IL. Assisted conception following poor ovarian response to gonadotrophin stimulation. Br J Obstet Gynaecol. 1997 Dec;104(12):1420-1. doi: 10.1111/j.1471-0528.1997.tb11020.x. No abstract available.
PubMed 9422028
Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
PubMed 21505041
Kyrou D, Kolibianakis EM, Venetis CA, Papanikolaou EG, Bontis J, Tarlatzis BC. How to improve the probability of pregnancy in poor responders undergoing in vitro fertilization: a systematic review and meta-analysis. Fertil Steril. 2009 Mar;91(3):749-66. doi: 10.1016/j.fertnstert.2007.12.077. Epub 2008 Jul 21.
PubMed 18639875
Pandian Z, McTavish AR, Aucott L, Hamilton MP, Bhattacharya S. Interventions for 'poor responders' to controlled ovarian hyper stimulation (COH) in in-vitro fertilisation (IVF). Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD004379. doi: 10.1002/14651858.CD004379.pub3.
PubMed 20091563
Jeve YB, Bhandari HM. Effective treatment protocol for poor ovarian response: A systematic review and meta-analysis. J Hum Reprod Sci. 2016 Apr-Jun;9(2):70-81. doi: 10.4103/0974-1208.183515.
PubMed 27382230
Bastu E, Buyru F, Ozsurmeli M, Demiral I, Dogan M, Yeh J. A randomized, single-blind, prospective trial comparing three different gonadotropin doses with or without addition of letrozole during ovulation stimulation in patients with poor ovarian response. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:30-4. doi: 10.1016/j.ejogrb.2016.05.027. Epub 2016 May 24.
PubMed 27236602
Ertzeid G, Storeng R. The impact of ovarian stimulation on implantation and fetal development in mice. Hum Reprod. 2001 Feb;16(2):221-5. doi: 10.1093/humrep/16.2.221.
PubMed 11157810
Van der Auwera I, D'Hooghe T. Superovulation of female mice delays embryonic and fetal development. Hum Reprod. 2001 Jun;16(6):1237-43. doi: 10.1093/humrep/16.6.1237.
PubMed 11387298
Baker VL, Brown MB, Luke B, Smith GW, Ireland JJ. Gonadotropin dose is negatively correlated with live birth rate: analysis of more than 650,000 assisted reproductive technology cycles. Fertil Steril. 2015 Nov;104(5):1145-52.e1-5. doi: 10.1016/j.fertnstert.2015.07.1151. Epub 2015 Aug 18.
PubMed 26297646
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
Fanchin R, Cunha-Filho JS, Schonauer LM, Kadoch IJ, Cohen-Bacri P, Frydman R. Coordination of early antral follicles by luteal estradiol administration provides a basis for alternative controlled ovarian hyperstimulation regimens. Fertil Steril. 2003 Feb;79(2):316-21. doi: 10.1016/s0015-0282(02)04574-0.
PubMed 12568840
Bosdou JK, Venetis CA, Kolibianakis EM, Toulis KA, Goulis DG, Zepiridis L, Tarlatzis BC. The use of androgens or androgen-modulating agents in poor responders undergoing in vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2012 Mar-Apr;18(2):127-45. doi: 10.1093/humupd/dmr051. Epub 2012 Feb 3.
PubMed 22307331
Massin N, Cedrin-Durnerin I, Coussieu C, Galey-Fontaine J, Wolf JP, Hugues JN. Effects of transdermal testosterone application on the ovarian response to FSH in poor responders undergoing assisted reproduction technique--a prospective, randomized, double-blind study. Hum Reprod. 2006 May;21(5):1204-11. doi: 10.1093/humrep/dei481. Epub 2006 Feb 13.
PubMed 16476678
Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
PubMed 16517559

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Effect of Follicular Preparation With Testosterone in Poor Ovarian Response: a Randomized Controlled Clinical Trial (TESTOPRIM)
ClinicalTrials.gov ID: NCT03378713
Acronym / sponsor ID: TESTOPRIM / TESTOPRIM
Conditions: Infertility, Female
Keywords: Poor Ovarian Response
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
Study start: 7 Aug 2017 (actual)
Primary completion: 11 Feb 2019 (actual)
Study completion: 11 Feb 2019 (actual)
First posted: 20 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study population will include only patients diagnosed with POR based on ESHRE Bologna criteria, in order to homogenize the population and allow comparisons with other studies in the future.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
GROUP 1: Long testosterone	Experimental	Drug: GROUP 1: Long testosteroneApplication of testosterone in transdermal gel during the 2 cycles prior to initiation of controlled ovarian stimulation and until the onset of second menstruation (approximately 56 days). The COS begins the day after the last testosterone application.
GROUP 2: Short testosterone	Active comparator	Drug: GROUP 2: Short testosteroneApplication of testosterone in transdermal gel begins on day 21 of menstrual cycle, from the luteal phase of the cycle prior to initiation of controlled ovarian stimulation and until menstruation (approximately 10 days). The COS begins the day after the last testosterone application.
GROUP 3: Control	Active comparator	Drug: GROUP 3: ControlThe COS starts directly on the second day of the cycle without prior medication.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed Informed consent prior to the completion of any procedure related to the clinical trial.
Female older than 18 years old at the time of randomization.
Prior diagnosis of poor ovarian response (POR) according to ESHRE Bologna criteria. Patients must meet at least 2 of the following:

Key exclusion criteria (10 listed)

Presence of uterine malformations, corrected or not.
Presence of uterine pathology defined as submucous myomas or endometrial polyps, documented by transvaginal ultrasound.
Couples with severe male factor defined as REM <1 or azoospermia.
Hydrosalpinx unilateral or bilateral uncorrected.
Perimenopausal patients with irregular menstrual cycles.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GROUP 1: Long testosteroneApplication of testosterone in transdermal gel during the 2 cycles prior to initiation of controlled ovarian stimulation and until the onset of second menstruation (approximately 56 days). The COS begins the day after the last testosterone application	Drug	GROUP 1: Long testosterone
GROUP 2: Short testosteroneApplication of testosterone in transdermal gel begins on day 21 of menstrual cycle, from the luteal phase of the cycle prior to initiation of controlled ovarian stimulation and until menstruation (approximately 10 days). The COS begins the day after the last testosterone application.	Drug	GROUP 2: Short testosterone
GROUP 3: ControlThe COS starts directly on the second day of the cycle without prior medication.	Drug	GROUP 3: Control

Primary outcome

Total number of mature oocytes obtained at follicular puncture.
Time frame: 36 hours after induction of ovulation with recombinant HCG.
Determining whether a Follicular preparation with transdermal testosterone increases the number of mature oocytes retrieved in patients diagnosed with Poor Ovarian Response and which testosterone administration regimen is more effective for this purpose.

17 secondary outcomes

Number of obtained embryos
Time frame: 6 days after ovarian puncture.
Number of antral follicles at the start of stimulation
Time frame: Time E: prior to controlled ovarian stimulation (at the beginning of the third cycle after inclusion and randomization, approximately 56 days after Day 0)
Initiation rate
Time frame: Time E: prior to controlled ovarian stimulation (at the beginning of the third cycle after inclusion and randomization, approximately 56 days after Day 0)
Number of days of stimulation duration
Time frame: Time P (time of follicular puncture): 36 hours after the induction
Number of total follicles and greater than 16 mm
Time frame: Time I (Day of induction): 10-12 days after controlled ovarian stimulation
Total dose of gonadotrophins used
Time frame: Time I (Day of induction): 10-12 days after controlled ovarian stimulation
Cancellation rate due to lack of ovarian response
Time frame: Time C: 10-12 days after controlled ovarian stimulation
Number of cumulus-oocyte complexes recovered on day of follicular puncture
Time frame: Time P (time of follicular puncture): 36 hours after the induction
Fertilization rate
Time frame: 24 hours after the puncture
Rate of cycles that achieve embryo transfer
Time frame: Time ET ( day of embryo transfer): 4-5 days after the stimulation
Number of good quality embryos available
Time frame: 48-72 hours after puncture
Number of embryos transferred
Time frame: Time ET (day of embryo transfer): 4-5 days after the stimulation
Number of cycles with supernumerary embryos to freeze
Time frame: 6 days after embryo transfer
Ongoing pregnancy rate per cycle started and per transfer
Time frame: 70-75 days after embryo transfer
Clinical pregnancy rate per cycle started and per transfer
Time frame: 30-35 days after embryo transfer
Miscarriage rate
Time frame: At 11-13 weeks of pregnancy, if there is no previous news of the patient (Trial completion time)
Serum hormone levels
Time frame: Day 0; Time I (day of induction): 10-12 days after controlled ovarian stimulation; and Time E (prior to controlled ovarian stimulation: at the beginning of the third cycle after inclusion and randomization, approximately 56 days after Day 0)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
Background: PubMed 12638782Tarlatzis BC, Zepiridis L, Grimbizis G, Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update. 2003 Jan-Feb;9(1):61-76. doi: 10.1093/humupd/dmg007.
Background: PubMed 9422028Gorgy A, Naumann N, Bates S, Craft IL. Assisted conception following poor ovarian response to gonadotrophin stimulation. Br J Obstet Gynaecol. 1997 Dec;104(12):1420-1. doi: 10.1111/j.1471-0528.1997.tb11020.x. No abstract available.
Background: PubMed 21505041Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
Background: PubMed 18639875Kyrou D, Kolibianakis EM, Venetis CA, Papanikolaou EG, Bontis J, Tarlatzis BC. How to improve the probability of pregnancy in poor responders undergoing in vitro fertilization: a systematic review and meta-analysis. Fertil Steril. 2009 Mar;91(3):749-66. doi: 10.1016/j.fertnstert.2007.12.077. Epub 2008 Jul 21.
Background: PubMed 20091563Pandian Z, McTavish AR, Aucott L, Hamilton MP, Bhattacharya S. Interventions for 'poor responders' to controlled ovarian hyper stimulation (COH) in in-vitro fertilisation (IVF). Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD004379. doi: 10.1002/14651858.CD004379.pub3.
Background: PubMed 27382230Jeve YB, Bhandari HM. Effective treatment protocol for poor ovarian response: A systematic review and meta-analysis. J Hum Reprod Sci. 2016 Apr-Jun;9(2):70-81. doi: 10.4103/0974-1208.183515.
Background: PubMed 27236602Bastu E, Buyru F, Ozsurmeli M, Demiral I, Dogan M, Yeh J. A randomized, single-blind, prospective trial comparing three different gonadotropin doses with or without addition of letrozole during ovulation stimulation in patients with poor ovarian response. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:30-4. doi: 10.1016/j.ejogrb.2016.05.027. Epub 2016 May 24.
Background: PubMed 11157810Ertzeid G, Storeng R. The impact of ovarian stimulation on implantation and fetal development in mice. Hum Reprod. 2001 Feb;16(2):221-5. doi: 10.1093/humrep/16.2.221.
Background: PubMed 11387298Van der Auwera I, D'Hooghe T. Superovulation of female mice delays embryonic and fetal development. Hum Reprod. 2001 Jun;16(6):1237-43. doi: 10.1093/humrep/16.6.1237.
Background: PubMed 26297646Baker VL, Brown MB, Luke B, Smith GW, Ireland JJ. Gonadotropin dose is negatively correlated with live birth rate: analysis of more than 650,000 assisted reproductive technology cycles. Fertil Steril. 2015 Nov;104(5):1145-52.e1-5. doi: 10.1016/j.fertnstert.2015.07.1151. Epub 2015 Aug 18.
Background: PubMed 25955224Escriva 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.
Background: PubMed 12568840Fanchin R, Cunha-Filho JS, Schonauer LM, Kadoch IJ, Cohen-Bacri P, Frydman R. Coordination of early antral follicles by luteal estradiol administration provides a basis for alternative controlled ovarian hyperstimulation regimens. Fertil Steril. 2003 Feb;79(2):316-21. doi: 10.1016/s0015-0282(02)04574-0.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jessica Subirá principal investigator

Hospital Universitari i Politècnic La Fe, Valencia, Spain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GROUP 1: Long testosterone and GROUP 2: Short testosterone in people with Infertility, Female, 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 6 inclusion and 10 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 13 Aug 2019. 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 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?

Total number of mature oocytes obtained at follicular puncture. (time frame: 36 hours after induction of ovulation with recombinant HCG.). 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 NCT03378713, which also lists 27 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 13 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.