Use of PDE inhibitors for endometrial growth

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 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
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	PDE inhibitors and endometrial growth under clomiphene ovarian stimulation
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	31/08/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	30
Key inclusion criteria	1. Infertile patients candidates to clomiphene ovarian stimulation 2. Female 3. 18 to 42 years old
Key exclusion criteria	1. Smoking 2. Arterial hypertension 3. Prior uterine surgery
Date of first enrolment	01/09/2014
Date of final enrolment	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

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"	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 date	01/02/2016
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	We 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