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Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF

NCT03078569 — Phase 4, Unknown, 30 participants, Wolfson Medical Center

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Transdermal Testosterone for Poor Responders Undergoing IVF

RegistryNCT03078569
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment30 (Estimated)
SponsorWolfson Medical Center (Other gov)
ConditionsInfertility, Female
InterventionsTestosterone gel (Drug)
Datesstart 2017-03-01 (estimated), primary completion 2018-03-01 (estimated), completion 2018-07-01 (estimated), first posted 2017-03-13, last updated 2017-03-13
Locations1 site in Israel

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-Summary

This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to enhance ovarian response in poor responders.

a randomized controlled trial with two groups, treatment group with transdermal testosterone before IVF treatment and a control group with no treatment.

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+Detailed description

One of the major challenges of Assisted reproduction technology is treating women with low ovarian response,those women achieve very poor pregnancy rate with IVF.

in recent years there is a focus

+Arms and interventions

ArmTypeInterventionsDescription
testosterone gelExperimentalDrug: Testosterone geltestosterone gel treatment group
Control groupNo interventionwithout testosterone treatment
  • Testosterone gel (Drug), also known as testomax: treatment with testosterone gel

+Outcome measures

Primary outcomes

  • number of retrieved oocytes [2 year]: number of oocytes

Secondary outcomes

  • number of clinical pregnancies [2.5 years]: number of pregnancies with fetal cardiac activity

+Eligibility

Sex: Female, ages: 30 Years to 42 Years, accepts healthy volunteers

Inclusion Criteria:

* infertility patients undergoing ART regular menses normal function of thyroid, liver and kidney normal BMI (19.3-28.9) without use of any fertility drugs in the previous two months

Exclusion Criteria:

* patients with recurrent implantations failure (3 cycles and more) previous ovarian surgery uncontrolled medical illness severe endometriosis (stage 3-4) contraindication for testosterone use

+Locations (1)

FacilityCityCountryStatus
Wolfson MCHolonIsraelRecruiting

My Notes