ISRCTN ISRCTN95746843
DOI https://doi.org/10.1186/ISRCTN95746843
Secondary identifying numbers N/A
Submission date
28/07/2015
Registration date
11/08/2015
Last edited
22/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Daniel Humberto Mendez Lozano
Scientific

Batallón de San Patricio 112
Real de San Agustin
San Pedro Garza Garcia
66278
Mexico

Phone (52) 8115553109
Email danielmendez@itesm.mx

Study information

Study designRandomised single centre cross over study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePDE inhibitors and endometrial growth under clomiphene ovarian stimulation
Study objectives1. 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
Health condition(s) or problem(s) studiedInfertility. Poor endometrial growth.
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Tadalafil
Primary outcome measureEndometrial growth, using ultrasound scans at day 4, 8 and 10.
Secondary outcome measures1. Uterine artery pulsatility index
2. Uterine artery resistant index

Measured by ultrasound on Day 4, 8 and 10.
Overall study start date01/09/2014
Completion date31/08/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants30
Key inclusion criteria1. Infertile patients candidates to clomiphene ovarian stimulation
2. Female
3. 18 to 42 years old
Key exclusion criteria1. Smoking
2. Arterial hypertension
3. Prior uterine surgery
Date of first enrolment01/09/2014
Date of final enrolment31/08/2015

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

Tecnológico de Monterrey. Centro Médico Zambrano Hellion.
University/education

Batallón de San Patricio 112
Real de San Agustin
San Pedro Garza Garcia
66278
Mexico

Phone (52)88882141
Email danielmendez@itesm.mx
Website http://www.cmzh.com.mx http://emcs.mty.itesm.mx
ROR logo "ROR" https://ror.org/03ayjn504

Funders

Funder type

University/education

Monterrey Institute of Technology and Higher Education (Tecnológico de Monterrey)

No information available

CREASIS - Assisted Reproduction Center (Mexico)

No information available

Results and Publications

Intention to publish date01/02/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planWe plan to publish this study at the end of this year
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 28/12/2015 22/01/2019 Yes No

Editorial Notes

22/01/2019: Publication reference added