NCT03078569

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

March 8, 2017

Last Update Submit

March 8, 2017

Conditions

Infertility, Female

Keywords

Poor responders

Outcome Measures

Primary Outcomes (1)

  • number of retrieved oocytes

    number of oocytes

    2 year

Secondary Outcomes (1)

  • number of clinical pregnancies

    2.5 years

Study Arms (2)

testosterone gel

EXPERIMENTAL

testosterone gel treatment group

Drug: Testosterone gel

Control group

NO INTERVENTION

without testosterone treatment

Interventions

Testosterone gelDRUG

treatment with testosterone gel

Also known as: testomax
testosterone gel

Eligibility Criteria

Age30 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly women under IVF treatment
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson MC

Holon, Israel

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

amir Mr shalev, MD

CONTACT

97235028105amirshalev75@yahoo.com

ariel Mr weissman, Proffesor

CONTACT

97235028106ariel.weissman@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 13, 2017

Study Start

March 1, 2017

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)