Plain English Summary
Background and study aims
In some cases of infertility, fertilisation and the early post-fertilisation development occur normally, but the resulting embryos fail to implant in the uterus (womb). This problem can be caused by insufficient production of the hormone called progesterone by the ovary. This abnormality is often associated with hormonal treatment protocols used for in vitro fertilisation (IVF). To solve this problem, women treated by IVF are usually given extra progesterone after the embryo is transferred to the uterus. Recent data have shown that, in addition to progesterone administration, the production of progesterone by the patient’s own ovary can be stimulated by treating the patients with a gonadotropin releasing hormone (GnRH) agonist. The aim of this study is to evaluate the effects of a GnRH agonist on IVF outcomes and blood progesterone levels in a group of women with a previous failure of the technique, associated with low blood progesterone levels.
Who can participate?
Women between 25 and 40 years of age with a previous IVF failure associated with low blood progesterone levels after embryo transfer
What does the study involve?
The study compares outcomes of two consecutive attempts of IVF in the same patients. Unlike the first attempt, in the second attempt the patients are treated with a GnRH agonist during 2 weeks after embryo transfer to the uterus. Except for this difference, the patients receive the same treatment in both attempts. Clinical pregnancy rate (number of pregnancies divided by the number of embryo transfer procedures) is measured from medical records at 3 months after embryo transfer.
What are the possible benefits and risks of participating?
Patients may have better IVF outcomes in the second attempt, without any additional side effects.
Where is the study run from?
MARGen Clinic (Spain)
When is the study starting and how long is it expected to run for?
September 2016 to April 2018
Who is funding the study?
MARGen Clinic (Spain)
Who is the main contact?
1. Dr Raquel Mendoza-Tesarik
mendozatesarik@gmail.com
2. Dr Jan Tesarik
jtesarik@clinicamargen.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jan Tesarik
ORCID ID
http://orcid.org/0000-0003-4645-5804
Contact details
MARGen Clinic
Camino de Ronda 2
Granada
18006
Spain
+346 (0)637 6992
jtesarik@clinicamargen.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1976
Study information
Scientific title
Efficient treatment of luteal phase deficiency in HCG-triggered IVF cycles by prolonged administration of GnRH agonist after embryo transfer
Acronym
Study hypothesis
This study aimed to identify women with IVF failure associated with low serum progesterone levels on the days following embryo transfer and to evaluate the effects of GnRH agonist on serum progesterone and pregnancy in GnRH antagonist-controlled and HCG-triggered IVF cycles.
Ethics approval
Not applicable
Study design
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Luteal phase insufficiency in assisted reproduction
Intervention
In women who failed to get pregnant and had an abnormally low serum progesterone concentration after uterine transfer of embryos resulting from in vitro fertilisation, the protocol of the subsequent attempt was modified as follows. First, the treatment phase before embryo transfer, including ovarian stimulation, ovarian follicle puncture and oocyte recovery, in vitro fertilisation, and embryo in vitro culture and uterine transfer, were performed exactly as in the previous attempt. The only difference concerned the period after embryo transfer. In addition to direct progesterone administration, the patients were given daily subcutaneous injections of GnRH agonist (0.1 mg triptorelin) during 14 days following embryo transfer.
Intervention type
Drug
Phase
Not Applicable
Drug names
Triptorelin
Primary outcome measure
Clinical pregnancy rate (number of pregnancies divided by the number of embryo transfer procedures) is measured from medical records 3 months after embryo transfer
Secondary outcome measures
1. Implantation rate (number of gestational sacs containing a living embryo implanted in the uterus divided by the number of embryos transferred) is measured from medical records 6 weeks after embryo transfer
2. Serum progesterone concentration is measured using immunoassay at the 7th and 14th day after embryo transfer
3. Total dose of progesterone administered is measured from medical records at the 14th day after embryo transfer
Overall trial start date
01/09/2016
Overall trial end date
30/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women
2. Aged between 28 and 39 years,
3. Failed to become pregnant
4. Had low luteal-phase progesterone levels in a previous in vitro fertilization attempt
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
25
Participant exclusion criteria
1. Age of >40 years
2. Andrological gynecological and systemic pathologies unrelated to the corpus luteum function:
2.1. Azoospermia
2.2. Necrozoospermia
2.3. Uterine polyps and fibroids
2.4. Polycystic ovary syndrome
2.5. Endometriosis
2.6. Cushing syndrome
2.7. Diabetes
2.8. Hypothyreosis and hyperthyreosis
2.9. Body mass index >29
Recruitment start date
01/09/2016
Recruitment end date
31/12/2017
Locations
Countries of recruitment
Spain
Trial participating centre
MARGen Clinic
Camino de Ronda 2
Granada
18006
Spain
Sponsor information
Organisation
MARGen Clinic
Sponsor details
Camino de Ronda 2
Granada
18006
Spain
+34 (0)6063 76992
jtesarik@clinicamargen.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
MARGen Clinic
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Study results will be submitted to a specialized scientific journal during 2018.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list