Condition category
Pregnancy and Childbirth
Date applied
28/07/2015
Date assigned
11/08/2015
Last edited
11/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Phase II

Drug names

Tadalafil

Primary outcome measures

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 trial start date

01/09/2014

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infertile patients candidates to clomiphene ovarian stimulation
2. Female
3. 18 to 42 years old

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes