A new treatment protocol reducing the risk of implantation failure and early pregnancy loss after transfer of embryos resulting from in vitro fertilisation
| ISRCTN | ISRCTN45835041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45835041 |
| Secondary identifying numbers | 1976 |
- Submission date
- 06/06/2018
- Registration date
- 05/07/2018
- Last edited
- 04/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
MARGen Clinic
Camino de Ronda 2
Granada
18006
Spain
 ORCID ID |
0000-0003-4645-5804 |
|---|---|
| Phone | +346 (0)637 6992 |
| jtesarik@clinicamargen.com |
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Efficient treatment of luteal phase deficiency in HCG-triggered IVF cycles by prolonged administration of GnRH agonist after embryo transfer |
| Study objectives | 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(s) | Not applicable |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2016 |
| Completion date | 30/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 25 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
Granada
18006
Spain
Sponsor information
Hospital/treatment centre
Camino de Ronda 2
Granada
18006
Spain
| Phone | +34 (0)6063 76992 |
|---|---|
| jtesarik@clinicamargen.com | |
| Website | www.clinicamargen.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| 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 | Study results will be submitted to a specialized scientific journal during 2018. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
