Plain English Summary
Background and study aims
The objective of this study is to assess the impact of the drug tadalafil on endometrial growth (growth of the inner lining of the uterus, or womb), and blood flow to and from the uterus (measured by uterine artery pulsatility (PI)) and resistance index (RI)) in female patients being treated for infertility with clomiphene in order to encourage ovulation.
Who can participate?
Infertile female patients aged between 18-42 taking clomiphene to encourage ovulation.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are placed in cycle A. They are treated with 100mg clomiphene citrate per day from day 2 to day 6 of the cycle and 5mg tadalafil per day from the 4th day to the 10th day of the cycle. Those in group 2 are placed in cycle B. These participants are treated only with the 100mg clomiphene citrate per day from day 2 to day 6 of the cycle. After being treated in cycle A or B, all participants are then reallocated to the other cycle and treated accordingly. Endometrial growth, PI and RI are assessed for all participants on day 4, 8 and 12 of each cycle.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
The Zambrano Hellion Medical Center, Monterrey Institute of Technology (Mexico)
When is the study starting and how long is it expected to run for?
September 2014 to August 2015
Who is funding the study?
1. Monterrey Institute of Technology and Higher Education (Tecnológico de Monterrey) (Mexico)
2. CREASIS - Assisted Reproduction Center (Mexico)
Who is the main contact?
Dr Daniel Humberto Mendez Lozano
danielmendez@itesm.mx
Study website
Contact information
Type
Scientific
Contact name
Dr Daniel Humberto Mendez Lozano
ORCID ID
Contact details
Batallón de San Patricio 112
Real de San Agustin
San Pedro Garza Garcia
66278
Mexico
(52) 8115553109
danielmendez@itesm.mx
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
PDE inhibitors and endometrial growth under clomiphene ovarian stimulation
Acronym
Study hypothesis
1. Long lasting phosphodiesterase inhibitors decreases the uterine artery pulsatility index on clomiphene ovarian stimulation
2. Long lasting phosphodiesterase inhibitors improve the endometrial growth on clomiphene ovarian stimulation
Ethics approval(s)
Institutional Ethics Committee, 27/08/2013, ref: IPDE5EC
Study design
Randomised single centre cross over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Infertility. Poor endometrial growth.
Intervention
Patients will be randomized according to previously sealed envelopes in order to start with Cycle A or Cycle B.
1. Cycle A: patients will receive clomiphene citrate 100 mg/day from the 2nd to the 6th day of the cycle and also tadalafil 5 mg/day from the 4th day to the 10th day of the cycle.
2. Cycle B (control): patients will only receive clomiphene citrate 100 mg/day from the 2nd to the 6th day of the cycle.
All patients will be monitored until the evidence of clinical pregnancy by ultrasound.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Tadalafil
Primary outcome measure
Endometrial growth, using ultrasound scans at day 4, 8 and 10.
Secondary outcome measures
1. Uterine artery pulsatility index
2. Uterine artery resistant index
Measured by ultrasound on Day 4, 8 and 10.
Overall study start date
01/09/2014
Overall study end date
31/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Infertile patients candidates to clomiphene ovarian stimulation
2. Female
3. 18 to 42 years old
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
30
Participant exclusion criteria
1. Smoking
2. Arterial hypertension
3. Prior uterine surgery
Recruitment start date
01/09/2014
Recruitment end date
31/08/2015
Locations
Countries of recruitment
Mexico
Study participating centre
The Zambrano Hellion Medical Center, Monterrey Institute of Technology (Centro Medico Zambrano Hellion. Tecnológico de Monterrey)
Batallón de San Patricio 112
Real de San Agustin
San Pedro Garza Garcia
Monterrey
66278
Mexico
Sponsor information
Organisation
Tecnológico de Monterrey. Centro Médico Zambrano Hellion.
Sponsor details
Batallón de San Patricio 112
Real de San Agustin
San Pedro Garza Garcia
66278
Mexico
(52)88882141
danielmendez@itesm.mx
Sponsor type
University/education
Website
http://www.cmzh.com.mx http://emcs.mty.itesm.mx
ROR
Funders
Funder type
University/education
Funder name
Monterrey Institute of Technology and Higher Education (Tecnológico de Monterrey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
CREASIS - Assisted Reproduction Center (Mexico)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We plan to publish this study at the end of this year
Intention to publish date
01/02/2016
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/12/2015 | 22/01/2019 | Yes | No |