Use of PDE inhibitors for endometrial growth
ISRCTN | ISRCTN95746843 |
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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
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
Scientific
Batallón de San Patricio 112
Real de San Agustin
San Pedro Garza Garcia
66278
Mexico
Phone | (52) 8115553109 |
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danielmendez@itesm.mx |
Study information
Study design | Randomised single centre cross over study |
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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 |
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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
Real de San Agustin
San Pedro Garza Garcia
Monterrey
66278
Mexico
Sponsor information
University/education
Batallón de San Patricio 112
Real de San Agustin
San Pedro Garza Garcia
66278
Mexico
Phone | (52)88882141 |
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danielmendez@itesm.mx | |
Website | http://www.cmzh.com.mx http://emcs.mty.itesm.mx |
https://ror.org/03ayjn504 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
Intention to publish date | 01/02/2016 |
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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